Press Releases
San Jose, CA and Göttingen, Germany, August 17, 2010 – Chronix Biomedical today reported that it has significantly expanded and accelerated its biomarker development capabilities with the installation of Germany’s first state-of-the-art high-throughput DNA mass sequencer at the University of Göttingen, Chronix’s long-time collaborator. Chronix is developing disease-specific biomarkers based on DNA fragments that are released into the bloodstream by damaged and dying (apoptotic) cells. Chronix‘s serum DNA biomarkers are applicable to a wide range of cancers and other chronic diseases.
“The advent of next-generation mass sequencers is transformational for development of our biomarker discovery and detection programs, and we are delighted to have access to this state-of-the-art system in conjunction with our colleagues at the University of Göttingen,” said Dr. Ekkehard Schütz, vice president of research at Chronix Biomedical. "Our proprietary technology has demonstrated excellent accuracy in the early detection of breast cancer and prostate cancer, and these new mass sequencing capabilities will allow us to rapidly develop tests for cancer and other chronic diseases.”
San Jose, California-based Chronix has research facilities in Göttingen, Germany, and its senior scientists are affiliated with the University’s Institute of Veterinary Medicine, which is home to the new next-generation sequencer. The new system allows Chronix to screen and analyze 25-times more genomes each month far more cost-effectively than was possible with older methods. It has reduced the time needed to screen a genome by about 80%, while improving reproducibility of the results. The new system has already enhanced the performance of Chronix’s initial tests for breast and prostate cancer, and is expected to accelerate development and commercialization efforts across the board.
“Access to this advanced mass sequencer will enable us to speed-up generation of the databases and related information that are prerequisites for development and commercialization of our apoptotic DNA biomarker technology,” noted Dr. Howard Urnovitz, CEO of Chronix. “The Chronix technology has shown early utility in several cancers and in CNS diseases such as multiple sclerosis and BSE. It has the potential to transform disease detection and monitoring, accelerate clinical research, enable development of companion diagnostics and help realize the goal of personalized disease management.”
Dr. Urnovitz continued, “Among the advantages of our approach are its versatility across applications and the fact that it is platform agnostic in regard to analytic systems. This flexibility means our technology can provide medically valuable ‘content’ in a wide variety of settings, and we intend to collaborate with a diverse group of partners to ensure its wide availability.”
Chronix researchers have developed proprietary diagnostic databases and related information using algorithms they developed to detect, analyze and identify disease-related fragments of DNA that are released into the bloodstream by apoptotic cells. This apoptotic DNA originates from a limited number of chromosomal regions, or “hotspots,” on the genome that are specific to each illness. By focusing on these genomic hotspots, the Chronix tests can reliably detect the presence of cancer without having first to isolate and analyze tumor cells, an important advantage.
"The tremendous increase in speed and cost-effectiveness the Life Technologies SOLiD4 system provides is allowing us to dramatically accelerate development of the proprietary diagnostic databases and related information that are the foundation for our tests based on serum apoptotic DNA,” said. Dr. Julia Beck, Laboratory Manager at Chronix. “The platform agnostic flexibility of our technology allows us to select the hardware with the optimal performance criteria, and results to date with this highly automated sequencer are very encouraging."
The Chronix approach has been validated in a number of peer-reviewed settings. In an oral presentation at the 2010 ASCO Annual Meeting, Chronix researchers presented data from 575 individuals showing that its assay detected breast cancer and invasive prostate cancer with 92% sensitivity and 100% specificity. These are encouraging results when compared to currently used early screening methods for these conditions. Additional published studies have demonstrated that the Chronix approach can identify the presence or absence of active disease in multiple sclerosis patients and that it can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity.
Based on these encouraging findings, Chronix recently launched a “For Investigational Use Only” (IUO) testing service that enables cancer researchers to monitor the status of patients in their clinical trials with a high level of sensitivity and specificity. The new mass sequencer will allow for more rapid and cost-effective screening of large quantities of IOU samples, allowing Chronix to meet increasing demand for the service from clinical investigators while also conducting studies to expand its menu of tests.
Commercial applications for veterinary use of the Chronix technology, including tests for the early detection of BSE, or mad cow disease, are in development in conjunction with the University of Calgary.
University of Göttingen Press release
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It is currently conducting studies in other cancers. The company initially plans to offer an Apoptotic Serum DNA testing service to cancer clinical researchers “For Investigational Use Only” to track disease recurrence and monitor treatment. Chronix is headquartered in San Jose, California and has research facilities in Germany.
Chicago, IL and San Jose, CA, June 7, 2010 – Chronix Biomedical today reported new data further demonstrating that its DNA blood tests have the potential to accurately detect early stage breast and prostate cancers. Chronix’s proprietary technology identifies disease-specific genetic fingerprints based on DNA fragments that are released into the bloodstream by damaged and dying (apoptotic) cells. In this new study of 575 individuals, Chronix’s assays detected and identified DNA fingerprints in the blood that indicated the presence of prostate or breast cancer with 92% sensitivity and 100% specificity, significantly outperforming the published accuracy data for current diagnostic methods. The new study results will be presented in an oral session today at the 2010 ASCO Annual Meeting in Chicago.
Breast cancer expert, Steven Narod, M.D., F.R.C.P.C., noted: “These new data, although early, provide further evidence that Chronix’s proprietary DNA blood test may represent a new diagnostic and prognostic platform that can identify cancer earlier and more accurately than is currently possible. I am pleased to be working with Chronix to further validate these promising findings.” Dr. Narod is Director of the Familial Breast Cancer Research Unit at Women’s College Research Institute, an affiliate of the University of Toronto.
The tests use proprietary algorithms developed by Chronix researchers to detect, analyze and identify cancer-related fragments of DNA that are released into the bloodstream by apoptotic cells. Chronix researchers consistently find that this apoptotic DNA in the blood originates from a limited number of regions, or “hotspots,” on the genome that are specific to each cancer. According to the data to be presented today, the presence of DNA fragments from any one of the 29 unique “hotspots” associated with breast cancer indicates that breast cancer is present in the patient. The presence of DNA fragments from any one of the 32 unique “hotspots” associated with prostate cancer, which are different from the breast cancer “hotspots,” is indicative of the presence of prostate cancer.
“By focusing on these blood-borne genomic ‘hotspots,’ we can reliably detect the presence of cancer without having first to isolate and analyze the tumor cells,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix and a co-author of the study. “If verified by further studies, our Chronix blood-based assays would make it possible to diagnose cancer at its earliest stages, track progress as patients undergo treatment and personalize treatment using patients’ disease-specific genomic fingerprints.”
The testing involved 575 individuals: 178 with early stage breast cancer, 197 with invasive prostate cancer and 200 healthy controls. The Chronix assay detected breast cancer with 92% sensitivity and 100% specificity. Although not directly comparable, for reference it is noteworthy that data from a large study of U.S. mammography screening programs reported an overall specificity of 92.3% and sensitivity of just 75%, with lower figures for some populations such as younger women. The Chronix assay also detected invasive prostate cancer with 92% sensitivity and 100% specificity. In contrast, the widely used PSA (prostate specific antigen) test has previously demonstrated 85% sensitivity and a specificity of just 25% to 35%. If the Chronix data are confirmed in larger studies, they have the potential to reduce the current rate of false positive and false negative results that contribute to poorer patient outcomes and higher healthcare costs.
Previous published studies have demonstrated that the Chronix approach can identify the presence or absence of active disease in multiple sclerosis patients and that it can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity. Commercial applications for veterinary use are in development in conjunction with the University of Calgary, including tests for the early detection of BSE, or mad cow disease.
Dr. Urnovitz added, “With these encouraging findings, we are launching a ‘For Investigational Use Only’ testing service that for the first time will enable cancer researchers to monitor the status of patients in their clinical trials with a high level of sensitivity and specificity, potentially accelerating clinical trials and increasing their chances for success.”
Patient data collected from this new service for clinical researchers along with additional planned clinical studies are expected to expand the database needed to obtain regulatory approval for the use of Chronix assays in ongoing cancer patient care.
Oral presentation: “Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer” (Abstract #10505)
June 7, 2010, 3:15 PM CT, Room S100a
About Chronix Biomedical (ASCO booth #6052)
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It is currently conducting studies in other cancers. The company initially plans to offer an Apoptotic Serum DNA testing service to cancer clinical researchers “For Investigational Use Only” to track disease recurrence and monitor treatment. Chronix is headquartered in San Jose, California and has research facilities in Germany.
San Jose, CA, June 2, 2010 – Chronix Biomedical today announced that it will launch a new disease detection and monitoring service for cancer researchers at the upcoming 2010 ASCO Annual Meeting. The “For Investigational Use Only” laboratory-based testing service uses Chronix’s breakthrough approach—the Chronix Apoptotic DNA Blood Test—which analyzes apoptotic DNA from dead and dying cells to identify and track ongoing changes associated with specific cancers and other chronic diseases. Chronix’s proprietary blood test has been shown to accurately detect disease much sooner than other testing methodologies. The Chronix test also reports information that may have utility for selecting the best treatment for each patient. The new service will initially be offered to cancer researchers in the medical oncology and pharmaceutical research communities.
“Our laboratory-based testing service will enable cancer researchers for the first time to monitor the disease status of patients in their clinical trials with a high level of sensitivity and specificity using a simple blood test,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “In addition to our promising breast and prostate cancer data, our scientists are developing assays for other cancers. This new service provides us with a unique opportunity to aid cancer researchers while also expanding the database that will be needed to support the use of our assays in ongoing patient care.”
A growing body of peer-reviewed data shows that the Chronix blood test can detect cancer at the earliest stages. Chronix will present data at ASCO from a study of 575 individuals showing that it correctly identified the presence of prostate cancer or breast cancer with 92% sensitivity and 100% specificity, using the unique algorithms it has developed to detect and identify disease-specific DNA fragments in the blood from apoptotic cells. If confirmed in larger studies, these results would significantly outperform current diagnostic tests for these cancers. Chronix will discuss the breast and prostate cancer study results in an oral ASCO session on Monday, June 7 at 3:15 PM CT.*
The initial focus of the Chronix Apoptotic Serum DNA Testing Service is to offer researchers an affordable and reliable tool providing early information on the cancer status of patients in their clinical trials. In addition, because the Chronix technology can pinpoint specific DNA-related damage to the patient’s cells, this “personalized medicine” approach may make it possible to analyze each patient’s profile and then to match those profiles to treatment outcomes. These analyses could provide rapid feedback to researchers on the likely efficacy of treatment options and could potentially serve as surrogate biomarkers of the efficacy of different treatments.
The new Chronix laboratory service is supporting the work of Dr. Jean-Francois Boileau at the Odette Cancer Centre at Sunnybrook Health Services Centre in Toronto. Dr. Boileau, a surgical oncologist with the Centre’s Breast Care Team, has been an investigator for multiple breast cancer trials and is currently the Principal Investigator of a major foundation-funded study of the utility of sentinel node biopsy following neoadjuvant chemotherapy.
Dr. Boileau commented, “It is with great enthusiasm that we will be conducting studies aimed at validating the early results from the Chronix Apoptotic Serum DNA Testing Service, which has shown the ability to distinguish with great accuracy those women who have early breast cancer from those who do not. Also, we will be evaluating whether the Chronix test could be used to predict how different individuals will respond to different breast cancer treatments. We look forward to helping to verify whether the Chronix assay will prove to be an effective way to identify breast cancer at an early stage and if it could be useful in helping to tailor the individual’s therapy. The fact that this test can be run using a simple blood sample is a major advantage, and if these new studies validate the early findings, the Chronix approach could be a major contribution to the breast cancer field.”
Previously published studies have demonstrated that the Chronix technology can identify the presence or absence of active disease in multiple sclerosis patients and that it can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity. Commercial applications for veterinary use are in development with the University of Calgary, including a test for the early detection of BSE, or mad cow disease.
Learn More About This Groundbreaking Resource
Oncologists, health providers, drug developers and other organizations interested in learning how the Chronix Apoptotic Serum DNA Testing Service can positively impact their cancer clinical research can call (408) 960-2306 for more information, or email Chronix at info@chronixbiomedical.com.
Researchers are invited to visit the Chronix booth (#6052) at ASCO for further information.
*Abstract #10505, “Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer,” 3:15 PM CT, June 7, 2010, Room S100a
About Chronix Biomedical (ASCO booth #6052)
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It is currently conducting studies in other cancers. The company initially plans to offer an Apoptotic Serum DNA Testing Service to cancer clinical researchers “For Investigational Use Only” to track disease recurrence and monitor treatment. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX TO PRESENT DATA AT ASCO THAT COULD REVOLUTIONIZE THE DIAGNOSTIC PARADIGM FOR CANCER
San Jose, CA, May 21, 2010 – Chronix Biomedical today reported a summary of data supporting the utility of its serum DNA blood tests for the early and accurate detection of breast cancer and prostate cancer. The unique testing algorithms developed by Chronix detected and correctly identified DNA fragments in the blood from dying (apoptotic) cancer cells with 92% sensitivity and 100% specificity in both prostate cancer and breast cancer. If confirmed in larger studies, these results would significantly outperform those obtained from current diagnostics for these cancers. The new data, which were generated from 575 individuals, provide further evidence that Chronix’s proprietary serum DNA assays may represent a new diagnostic and prognostic platform that can identify cancer and other chronic diseases earlier and more accurately than is currently possible. The data will be presented in an oral session at the 2010 ASCO Annual Meeting on Monday, June 7 at 3:00 PM CT.*
“These early data suggest the Chronix assays have potential beyond the diagnostic tools available today in my specialty of breast cancer,” said Steven Narod, M.D., F.R.C.P.C., Director of the Familial Breast Cancer Research Unit at Women’s College Research Institute, an affiliate of the University of Toronto. “If these encouraging data hold up in further testing, this approach to cancer diagnostics and prognostics has the potential to change how we diagnose, monitor and manage many cancers. I am pleased to be working with Chronix to further validate these promising findings.”
A growing body of peer-reviewed data shows that the Chronix DNA-based blood tests can detect cancer recurrence at the earliest stages, and they also can provide insight into patient-specific response to treatment. Previous published studies have demonstrated their potential utility in breast cancer and multiple sclerosis. In conjunction with the University of Calgary, Chronix is also developing commercial applications for veterinary use, including tests for the early detection of BSE, or mad cow disease.
“With these encouraging findings, we are launching a ‘For Investigational Use Only’ laboratory-based testing service that for the first time will enable cancer researchers to monitor the status of patients in their clinical trials with a high level of sensitivity and specificity,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “This new service offers a unique opportunity to support clinical researchers while also expanding the database needed for regulatory approval for the use of our assays in ongoing patient care.”
Researchers are invited to visit the Chronix booth (#6052) at ASCO for further information and details.
*Abstract #10505, “Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer,” 3:15 PM CT, June 7, 2010, Room S100a.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays to clinical researchers as a “For Investigational Use Only” test in its research laboratories. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL PARTNERS WITH UNIVERSITY OF CALGARY TO COMMERCIALIZE SERUM DNA-BASED BLOOD TEST FOR MAD COW DISEASE
San Jose, California, April 13, 2010 – Chronix Biomedical today announced that it is partnering with the University of Calgary to develop a commercial version of its serum DNA-based blood test for the early detection of bovine spongiform encephalopathy (BSE), also known as mad cow disease. Chronix researchers have published data demonstrating that the company’s proprietary techniques can accurately detect BSE in cattle before any disease symptoms are evident. Currently BSE can only be definitively diagnosed with a post-mortem brain biopsy. Development of the commercial BSE assay is supported by a grant from the Alberta Livestock and Meat Agency (ALMA) and Genome Canada. Chronix intends to begin offering BSE testing services to the cattle industry once the commercial test is finalized and validated.
Chronix’s technology identifies disease-specific genetic fingerprints based on circulating DNA that is released into the bloodstream by damaged and dying cells. The BSE test represents the first commercial application of Chronix’s technology, which is primarily being developed for the detection and monitoring of human diseases including cancer and chronic conditions. Chronix recently published studies showing that it can identify the presence or absence of active disease in multiple sclerosis patients and that its approach can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity. Further validating the Chronix technology, researchers will disclose additional breast and prostate cancer study results in an upcoming oral presentation at the 2010 ASCO Annual Meeting.
“The technology from Chronix is the first to demonstrate the potential to achieve our goal of an accurate, cost-effective assay that will revolutionize BSE testing, making it economically and logistically feasible to screen all cattle in the food chain before BSE symptoms appear,” said Christoph Sensen, Ph.D., Professor at the University of Calgary Faculty of Medicine and Principal Investigator of the grant research program. “This effort is critically important because the risk of introducing BSE into the food chain continues to worry consumers and hinder international trade."
Chronix’s proprietary serum DNA blood tests are based on a growing body of publications showing that circulating DNA fragments can be identified and analyzed to provide a diagnostic window into changes associated with specific diseases. These changes can be used to track the presence of disease months or years before symptoms appear
Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix stated: “Our technology for the first time makes possible the early detection of BSE in an accurate, timely and cost-effective way. We appreciate the visionary support of ALMA and Genome Canada and look forward to working with our colleagues at the University of Calgary to develop a commercial BSE assay. Chronix is also currently developing additional serum DNA-based blood tests for human applications in cancer and chronic neurological conditions.”
BSE was among the first diseases that Chronix showed could be detected using its novel approach. In a 2009 publication in Nucleic Acids Research, scientists working with Chronix demonstrated that their blood test based on circulating DNA sequences could identify the presence of BSE and a related condition long before symptoms were evident.
ASCO abstract #10505: Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer, June 7, 2010.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays in a CLIA laboratory setting. Chronix is headquartered in San Jose, California and has research facilities in Germany.
NEWLY PUBLISHED DATA SHOWS CHRONIX BIOMEDICAL’S SERUM DNA ASSAYS CAN MONITOR DISEASE ACTIVITY AND TREATMENT RESPONSE IN MULTIPLE SCLEROSIS
San Jose, California, April 6, 2010 – Chronix Biomedical today announced publication of a study that supports the utility of its serum DNA blood tests to predict clinical status and monitor disease activity and response to treatment in multiple sclerosis (MS). Chronix Biomedical uses proprietary technology to identify disease-specific genetic fingerprints based on the circulating DNA that is released into the bloodstream by damaged and dying cells. A growing body of publications from Chronix and other researchers shows that this circulating DNA can be identified and analyzed to provide a diagnostic window into ongoing changes in the genome associated with specific diseases—changes that can be used to track the presence or absence of active disease. This new study is the first to show that the Chronix approach can be used to monitor the clinical status of a chronic disease. The findings are published in the current online edition of the Journal of Molecular Diagnostics.*
“These positive data further validate the premise underlying the Chronix approach, showing that the many genetic anomalies associated with active and stable relapsing-remitting MS can be detected by analyzing DNA fragments circulating in the blood serum,” said Mario Clerici, M.D., Chair of Immunology, Department of Biomedical Sciences and Technologies, University of Milano, Milan, Italy and a co-author of the study. “The prognostic value achieved in this study supports the ability of this new approach to help manage relapsing-remitting multiple sclerosis, potentially offering clinicians a new tool to easily assess which MS treatment options are most effective for their patients, as well as providing critical information that will facilitate development of the next generation of MS therapeutics."
In the study, researchers applied advanced analytical techniques developed by Chronix to identify genomic DNA fingerprints in the bloodstream of 28 MS patients known to have relapsing or stable disease as compared to 50 healthy volunteers. Researchers were able to distinguish the MS patients from the healthy volunteers and they also were able to use these circulating DNA fingerprints to differentiate periods of active disease attacks from the stable periods of disease remission characterizing relapsing-remitting MS, which affects about 85% of MS patients.
William M. Mitchell, M.D., Ph.D., Professor of Pathology at Vanderbilt University and a co-author of the study noted,” The data from this study suggests that the Chronix quantitative blood test provides a simpler, safer and more cost effective approach to assessing the activity of investigational new drugs for MS. Development of new MS drugs is currently complicated by the fact that disease status is monitored using dye-enhanced MRI scans that are expensive and are associated with occasional toxicities. In addition, they can only show neurological damage after it has occurred, while the Chronix approach provides a real time measure of disease activity.”
The newly published MS data follows earlier work that demonstrated the ability of Chronix’s serum DNA-based assays to diagnose mad cow disease and chronic wasting disease in live animals, conditions that until now could only be diagnosed using post-mortem biopsies. These successful studies in three neurological disorders suggest that when specialized nerve cells die, they leave behind unique DNA fingerprints characteristic of the cell of origin. Chronix researchers have figured out how to identify and apply these unique fingerprints to diagnose disease and monitor disease activity.
“These positive data further support the Chronix approach to detecting and monitoring diseases, including neurologic diseases such as MS,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “We are now preparing to offer laboratory testing services to support clinical trials for new neurologic drugs, initially focusing on MS and expanding to diseases such as Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease and autism. Eventually we intend to offer testing services that will allow physicians to monitor ongoing disease status and response to treatment in their patients with MS and other chronic neurological conditions.”
A publication in Molecular Cancer Research in March demonstrated the potential utility of the Chronix serum DNA assays in breast cancer. The findings demonstrated that the Chronix approach was able to detect invasive breast cancer with high diagnostic sensitivity and specificity, even at the earliest stage when tumors are very small.
Dr. Clerici is a member of the Chronix Medical Advisory Board and has an equity position in the company. Dr. Mitchell is an independent member of the Chronix Board of Directors and has an equity position in the company.
* “Serum DNA Motifs Predict Disease and Clinical Status in Multiple Sclerosis,” J Beck, H Urnovitz, M Saresella, D Caputo, M Clerici, M Mitchell, and E Schütz, J Mol Diag; 2010;12(5). Epub 12 Mar 2010.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays in a CLIA laboratory setting. Chronix is headquartered in San Jose, California and has research facilities in Germany.
NEWLY PUBLISHED DATA SHOWS CHRONIX BIOMEDICAL’S SERUM DNA ASSAYS CAN DETECT EARLY-STAGE BREAST CANCER
San Jose, California, March 9, 2010 – Chronix Biomedical today announced publication of a study that supports the utility of its serum DNA blood tests for the early and accurate detection of breast cancer. The Chronix tests detect the circulating DNA that is released into the blood stream by damaged and dying cells. A growing body of publications from Chronix and other researchers shows that this circulating DNA can be identified and analyzed to provide a diagnostic window into ongoing changes in the genome associated with specific diseases—changes that can be used to identify disease processes at an early stage and to track responses to treatment. This new study shows that the Chronix approach was able to detect invasive breast cancer with high diagnostic sensitivity and specificity, even at the earliest stage when tumors are very small. The findings are published in the current online edition of Molecular Cancer Research.*
“This study supports the potential of an entirely new approach to identifying cancer at its earliest stages when therapies may be most effective,” said William M. Mitchell, M.D., Ph.D., Professor of Pathology at Vanderbilt University School of Medicine and a co-author of the study. “The promising diagnostic sensitivity and specificity achieved in this study further confirm the value of circulating DNA for disease detection and suggest that laboratory tests using this approach may have the potential both to screen large populations for cancer before symptoms appear and to monitor patients for the recurrence of cancer once treated.”
In the study, researchers applied advanced analytical techniques developed by Chronix to identify genomic DNA associated with breast cancer that was released into the bloodstream of women known to have breast cancer but was not present in healthy women or in patients with other medical conditions. Using the Chronix method, breast cancer was accurately detected at a diagnostic specificity level of 95% with a calculated sensitivity of 90%. Although not directly comparable, for reference it is useful to note that data from a large study of U.S. mammography screening programs reported an overall specificity of 92.3% and sensitivity of 75%, with lower figures for some populations such as younger women.
“These positive data further validate the premise underlying the Chronix approach, showing that DNA circulating in the serum can be used to detect disease at its earliest stages with high levels of accuracy,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “We have now been able to translate these research findings into a diagnostic assay that is initially suitable for use in clinical cancer research applications, and look forward to rapidly advancing both the breast cancer program and our pipeline of tests for other cancers and life threatening conditions.”
Dr. Mitchell is an independent member of the Chronix Board of Directors and has an equity position in the company.
* “Next Generation Sequencing of Serum Circulating Nucleic Acids from Patients with Invasive Ductal Breast Cancer Reveals Differences to Healthy and Nonmalignant Controls,” J Beck, H Urnovitz, WM Mitchell, and E Schütz, Mol Cancer Research; 2009;8(3):335-42. Epub 9 Mar 2010.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays in a CLIA laboratory setting. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL APPOINTS INDUSTRY VETERAN PAUL E. FREIMAN AS CHAIRMAN
San Jose, California, July 15, 2009 – Chronix Biomedical, an innovator developing blood tests based on serum DNA for the early detection and management of cancer, today announced that Paul E. Freiman has been appointed Chairman of the Board of Directors. Mr. Freiman, the former CEO of Syntex Corporation and Neurobiological Technologies, Inc., brings Chronix a wealth of pharmaceutical and biotechnology experience from his more than 30 years of successful industry leadership.
“Access to routine tests that can identify cancer at an early stage is high on the wish lists of many oncologists and now Chronix has the capability to make this possible,” said Mr. Freiman. “I see the future of excellent health care treatment as dependent on personalized medicine. Chronix’s technology, which identifies critical molecular diagnostic markers, will facilitate achievement of this goal. I look forward to helping to advance this important technology as the company seeks partners for further development and commercialization.”
Chronix has developed technology that makes it possible to diagnose cancer before symptoms appear, and it does so using simple blood tests that can be easily integrated into routine medical practice. Chronix’s innovative blood tests work by capturing information contained in DNA released into the blood stream by damaged and dying cells. This circulating DNA provides a window into ongoing changes in the genome associated with disease, changes that can identify a disease process at its earliest stages and help track response to treatment. The Chronix approach has recently been validated in a number of peer-reviewed articles.
As former Chairman and Chief Executive Officer of Syntex Corporation, Mr. Freiman is credited with much of the marketing success of Syntex’s blockbuster product, Naprosyn®, and was responsible for moving the product to over-the-counter status, where it is marketed as Aleve®. He also was instrumental in the sale of Syntex to Roche Holdings for $5.3 billion.
“Paul Freiman assuming the Chairman position at Chronix is a testament to the potential of our revolutionary serum DNA-based technology to transform the early diagnosis and management of cancer,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “Paul’s impressive record of biomedical industry leadership spans pharmaceuticals, diagnostics, biologics and public advocacy. We are fortunate to have the benefit of his broad experience and strategic counsel as we advance our technology through clinical validation toward commercialization.”
More recently, Mr. Freiman was President and Chief Executive Officer of Neurobiological Technologies, Inc. He also has extensive board experience, currently serving as Chairman of the Board of Penwest Pharmaceuticals Co., while also serving on the boards of Otsuka America Pharmaceuticals, Inc., NeoPharm Inc., and NovaBay Pharmaceuticals, Inc. Formerly, Mr. Freiman was Chairman of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) and has chaired a number of key PhRMA committees. He holds a B.S. degree from Fordham University and an honorary doctorate from the Arnold & Marie Schwartz College of Pharmacy and Health Sciences of Long Island University.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis and management of chronic diseases and cancer. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to collaborate with a variety of partners to develop and market its serum DNA-based assays that have the potential to transform the management of a broad range of cancers and other conditions. Chronix is headquartered in San Jose, California and has research facilities in Germany.
NEWLY PUBLISHED STUDY USING CHRONIX TECHNOLOGY CONFIRMS SERUM DNA CAN IDENTIFY THE EARLY PRESENCE OF DISEASE
San Jose, California, June 23, 2009 – Chronix Biomedical today reported that a new study in a peer-reviewed journal further confirms the potential diagnostic and prognostic utility of using circulating fragments of DNA to detect early stage disease. These DNA fragments, referred to as serum DNA, are released into the blood stream in trace amounts during the disease process. Chronix Biomedical has developed proprietary technology that can find, isolate and identify these serum DNA sequences, enabling very early detection of an underlying disease state or of a change in response to treatment. The study in the current issue of the journal Zoonoses & Public Health1 demonstrated that using Chronix technology, researchers were able to identify specific signature sequences in serum DNA before clinical symptoms appeared in animals experimentally infected with BSE (mad cow disease).
“These new results add to the growing body of scientific data validating the value of serum DNA as an early indicator of disease, and also advance our unique ability to apply these findings to the development of laboratory tests for routine clinical use,” said Howard Urnovitz, Ph.D., CEO of Chronix. “Using our proprietary technology and next-generation sequencers, we were able to identify distinctive DNA signatures indicating the presence of BSE in all of the infected animals well before clinical symptoms appeared.”
These new findings follow three previous published studies demonstrating the utility of using serum DNA to identify human cancers, human infectious disease and BSE. For example, a study reported in the December issue of the journal Blood showed that serum DNA was able to identify a secondary cancer in a patient before it was clinically apparent.
Of special interest in this current study is the finding that these DNA signatures occurred primarily in non-coding regions of the genome, where geneticists typically would not look. Chronix scientists believe these findings may lead to a better understanding of the genetics of disease development, while advancing Chronix’s own ability to harness these early changes for diagnostic and prognostic applications.
1. Beck, J., Urnovitz, H., Groschup, M., Ziegler, U., Brenig, B., Schutz, E. (2009) Serum Nucleic Acids in an Experimental Bovine Transmissible Spongiform Encephalopathy Model. Zoonoses and Public Health. (Published Online May 20, 2009).
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis and management of chronic diseases and cancer. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in multiple myeloma and mad cow disease, and studies in other diseases are underway. The company plans to collaborate with a variety of partners to develop and market its serum DNA-based assays that have the potential to transform the management of a broad range of cancers and other conditions. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL SAYS THREE RECENT STUDIES SUPPORT THE UTILITY OF CIRCULATING DNA AS NOVEL DIAGNOSTICS FOR HUMAN CANCER, MAD COW DISEASE AND OTHER CONDITIONS
San Jose, California, March 10, 2009 – Chronix Biomedical - developing and applying proprietary techniques to detect and analyze circulating nucleic acid sequences for the diagnosis and management of disease - today reported that three recent studies published in peer-reviewed journals have further confirmed the potential diagnostic and prognostic utility of fragments of DNA and RNA that circulate in the blood, known as circulating nucleic acids (CNAs). Data from these studies confirm previous findings showing that CNAs can identify the presence of certain diseases in blood samples months to years before clinical symptoms appear.
“The recent publication of these three studies represents a major milestone in the recognition of CNAs as novel diagnostic tools,” said Howard Urnovitz, Ph.D., CEO of Chronix. “Our ability to accurately identify and characterize the presence of significant differences in CNA levels and sequences between healthy and diseased individuals demonstrates how CNAs would be used for diagnosis and disease management in conditions as diverse as bovine spongiform encephalopathy (mad cow disease) and human cancers.”
In the study appearing in the current online edition of Clinical Chemistry, scientists from Chronix applied ultra-high speed sequencing technology and proprietary data analysis tools to characterize and categorize the CNA markers present in multiple individuals. The resulting databases of CNAs associated with specific disease states can be used to identify persons with undiagnosed disease, and potentially, to track changes in disease status. For example, the study found that one of the presumed healthy volunteers was actually infected with hepatitis B.
This study follows publication in January of research from scientists at the University of Calgary, Canada, the University of Göttingen, Germany and Chronix showing the ability of a simple blood test based on circulating DNA sequences to identify the presence of bovine spongiform encephalopathy (BSE) and the related condition chronic wasting disease (CWD) in live animals long before symptoms were evident. This advance is especially significant since BSE can now only be confirmed by examining the brain tissue of dead animals. Following expected confirmation in larger studies, this new approach could revolutionize testing for BSE, making it economically and logistically feasible to screen all cattle in the food chain before BSE symptoms appear. The study was published in the journal Nucleic Acids Research.
A third reported study highlights the potential utility of CNAs in the management of cancer. Dr. Urnovitz, and Brian G.M. Durie, M.D., Medical Director and co-founder of the International Myeloma Foundation, identified specific DNA sequences circulating in the blood of a patient with the bone marrow cancer multiple myeloma and tracked variations in these sequences as the patient’s myeloma moved in and out of remission. There was also an unexpected finding when CNAs identified the development of a secondary cancer in this patient, before it was clinically apparent. This preliminary study is significant because it shows that CNAs can potentially be used to diagnose, monitor and manage cancer treatment. The abstract reporting this data was published in the journal Blood in connection with the December 2008 meeting of the American Society of Hematology.
“This approach opens the door to a new tool that will enable us to follow the progress of cancer treatment and give us an early warning when a myeloma patient is about to come out of remission,” said Dr. Durie. “This will allow us to stay ahead of the disease instead of waiting for the patient to get sick before we can act. That capability will represent a major change in the way we treat this cancer.”
Dr. Urnovitz concluded, “Even in these experiments we found unexpected results – undiagnosed hepatitis in one patient and a secondary cancer in another – confirming the utility of CNAs in finding unsuspected disease. With these multiple proof-of-concept experiments now completed, we are embarking on the studies needed to further confirm and commercialize this powerful new approach with important applications in personalized medicine and human health.”
Chronix intends to work with a number of industry partners to develop and commercialize its CNA technology for diagnostic and prognostic applications. These emerging markets for novel genetic-based assays have multi-billion dollar potential. Because the Chronix technology can identify early changes in disease status, it also can be used to generate surrogate measures for drug development studies aimed at distinguishing responder and non-responder patient subgroups. The company has recently initiated discussions with potential pharmaceutical partners.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis and management of chronic diseases and cancer. It has developed proprietary technology that measures and categorizes circulating nucleic acids, DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methods, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in mad cow disease and multiple myeloma, and studies in other diseases are underway. The company plans to collaborate with a variety of partners to develop and market its DNA-based assays that have the potential to transform the management of a broad range of cancers and other conditions. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL ADDS STATE-OF-THE-ART MASS SEQUENCING CAPABILITIES TO ACCELERATE DEVELOPMENT OF ITS DNA BIOMARKERS FOR EARLY DETECTION OF CANCER
-Advanced DNA Sequencer Allows Chronix to Speed Up and Expand Development of Its Serum DNA Biomarkers for Early Diagnosis and Monitoring of Cancer and Other Chronic Diseases-
-New Sequencing Capability Is Enabling Faster, More Cost-Effective Creation of Medically Valuable Biomarker Information with Broad Potential in Disease Detection and Management and Personalized Medicine-
San Jose, CA and Göttingen, Germany, August 17, 2010 – Chronix Biomedical today reported that it has significantly expanded and accelerated its biomarker development capabilities with the installation of Germany’s first state-of-the-art high-throughput DNA mass sequencer at the University of Göttingen, Chronix’s long-time collaborator. Chronix is developing disease-specific biomarkers based on DNA fragments that are released into the bloodstream by damaged and dying (apoptotic) cells. Chronix‘s serum DNA biomarkers are applicable to a wide range of cancers and other chronic diseases.
“The advent of next-generation mass sequencers is transformational for development of our biomarker discovery and detection programs, and we are delighted to have access to this state-of-the-art system in conjunction with our colleagues at the University of Göttingen,” said Dr. Ekkehard Schütz, vice president of research at Chronix Biomedical. "Our proprietary technology has demonstrated excellent accuracy in the early detection of breast cancer and prostate cancer, and these new mass sequencing capabilities will allow us to rapidly develop tests for cancer and other chronic diseases.”
San Jose, California-based Chronix has research facilities in Göttingen, Germany, and its senior scientists are affiliated with the University’s Institute of Veterinary Medicine, which is home to the new next-generation sequencer. The new system allows Chronix to screen and analyze 25-times more genomes each month far more cost-effectively than was possible with older methods. It has reduced the time needed to screen a genome by about 80%, while improving reproducibility of the results. The new system has already enhanced the performance of Chronix’s initial tests for breast and prostate cancer, and is expected to accelerate development and commercialization efforts across the board.
“Access to this advanced mass sequencer will enable us to speed-up generation of the databases and related information that are prerequisites for development and commercialization of our apoptotic DNA biomarker technology,” noted Dr. Howard Urnovitz, CEO of Chronix. “The Chronix technology has shown early utility in several cancers and in CNS diseases such as multiple sclerosis and BSE. It has the potential to transform disease detection and monitoring, accelerate clinical research, enable development of companion diagnostics and help realize the goal of personalized disease management.”
Dr. Urnovitz continued, “Among the advantages of our approach are its versatility across applications and the fact that it is platform agnostic in regard to analytic systems. This flexibility means our technology can provide medically valuable ‘content’ in a wide variety of settings, and we intend to collaborate with a diverse group of partners to ensure its wide availability.”
Chronix researchers have developed proprietary diagnostic databases and related information using algorithms they developed to detect, analyze and identify disease-related fragments of DNA that are released into the bloodstream by apoptotic cells. This apoptotic DNA originates from a limited number of chromosomal regions, or “hotspots,” on the genome that are specific to each illness. By focusing on these genomic hotspots, the Chronix tests can reliably detect the presence of cancer without having first to isolate and analyze tumor cells, an important advantage.
"The tremendous increase in speed and cost-effectiveness the Life Technologies SOLiD4 system provides is allowing us to dramatically accelerate development of the proprietary diagnostic databases and related information that are the foundation for our tests based on serum apoptotic DNA,” said. Dr. Julia Beck, Laboratory Manager at Chronix. “The platform agnostic flexibility of our technology allows us to select the hardware with the optimal performance criteria, and results to date with this highly automated sequencer are very encouraging."
The Chronix approach has been validated in a number of peer-reviewed settings. In an oral presentation at the 2010 ASCO Annual Meeting, Chronix researchers presented data from 575 individuals showing that its assay detected breast cancer and invasive prostate cancer with 92% sensitivity and 100% specificity. These are encouraging results when compared to currently used early screening methods for these conditions. Additional published studies have demonstrated that the Chronix approach can identify the presence or absence of active disease in multiple sclerosis patients and that it can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity.
Based on these encouraging findings, Chronix recently launched a “For Investigational Use Only” (IUO) testing service that enables cancer researchers to monitor the status of patients in their clinical trials with a high level of sensitivity and specificity. The new mass sequencer will allow for more rapid and cost-effective screening of large quantities of IOU samples, allowing Chronix to meet increasing demand for the service from clinical investigators while also conducting studies to expand its menu of tests.
Commercial applications for veterinary use of the Chronix technology, including tests for the early detection of BSE, or mad cow disease, are in development in conjunction with the University of Calgary.
University of Göttingen Press release
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It is currently conducting studies in other cancers. The company initially plans to offer an Apoptotic Serum DNA testing service to cancer clinical researchers “For Investigational Use Only” to track disease recurrence and monitor treatment. Chronix is headquartered in San Jose, California and has research facilities in Germany.
DATA PRESENTED AT ASCO SHOW CHRONIX BIOMEDICAL’S DNA BLOOD TESTS DETECT BREAST AND PROSTATE CANCER WITH 92% SENSITIVITY AND 100% SPECIFICITY
-Results Show Potential to Significantly Outperform Current Diagnostic Methods-
-Growing Body of Data Suggests Chronix’s Apoptotic DNA Assays May Represent a New Approach to Diagnostics and Prognostics in Cancer and Other Diseases-
-Learn More at Chronix ASCO Booth #6052-
Chicago, IL and San Jose, CA, June 7, 2010 – Chronix Biomedical today reported new data further demonstrating that its DNA blood tests have the potential to accurately detect early stage breast and prostate cancers. Chronix’s proprietary technology identifies disease-specific genetic fingerprints based on DNA fragments that are released into the bloodstream by damaged and dying (apoptotic) cells. In this new study of 575 individuals, Chronix’s assays detected and identified DNA fingerprints in the blood that indicated the presence of prostate or breast cancer with 92% sensitivity and 100% specificity, significantly outperforming the published accuracy data for current diagnostic methods. The new study results will be presented in an oral session today at the 2010 ASCO Annual Meeting in Chicago.
Breast cancer expert, Steven Narod, M.D., F.R.C.P.C., noted: “These new data, although early, provide further evidence that Chronix’s proprietary DNA blood test may represent a new diagnostic and prognostic platform that can identify cancer earlier and more accurately than is currently possible. I am pleased to be working with Chronix to further validate these promising findings.” Dr. Narod is Director of the Familial Breast Cancer Research Unit at Women’s College Research Institute, an affiliate of the University of Toronto.
The tests use proprietary algorithms developed by Chronix researchers to detect, analyze and identify cancer-related fragments of DNA that are released into the bloodstream by apoptotic cells. Chronix researchers consistently find that this apoptotic DNA in the blood originates from a limited number of regions, or “hotspots,” on the genome that are specific to each cancer. According to the data to be presented today, the presence of DNA fragments from any one of the 29 unique “hotspots” associated with breast cancer indicates that breast cancer is present in the patient. The presence of DNA fragments from any one of the 32 unique “hotspots” associated with prostate cancer, which are different from the breast cancer “hotspots,” is indicative of the presence of prostate cancer.
“By focusing on these blood-borne genomic ‘hotspots,’ we can reliably detect the presence of cancer without having first to isolate and analyze the tumor cells,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix and a co-author of the study. “If verified by further studies, our Chronix blood-based assays would make it possible to diagnose cancer at its earliest stages, track progress as patients undergo treatment and personalize treatment using patients’ disease-specific genomic fingerprints.”
The testing involved 575 individuals: 178 with early stage breast cancer, 197 with invasive prostate cancer and 200 healthy controls. The Chronix assay detected breast cancer with 92% sensitivity and 100% specificity. Although not directly comparable, for reference it is noteworthy that data from a large study of U.S. mammography screening programs reported an overall specificity of 92.3% and sensitivity of just 75%, with lower figures for some populations such as younger women. The Chronix assay also detected invasive prostate cancer with 92% sensitivity and 100% specificity. In contrast, the widely used PSA (prostate specific antigen) test has previously demonstrated 85% sensitivity and a specificity of just 25% to 35%. If the Chronix data are confirmed in larger studies, they have the potential to reduce the current rate of false positive and false negative results that contribute to poorer patient outcomes and higher healthcare costs.
Previous published studies have demonstrated that the Chronix approach can identify the presence or absence of active disease in multiple sclerosis patients and that it can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity. Commercial applications for veterinary use are in development in conjunction with the University of Calgary, including tests for the early detection of BSE, or mad cow disease.
Dr. Urnovitz added, “With these encouraging findings, we are launching a ‘For Investigational Use Only’ testing service that for the first time will enable cancer researchers to monitor the status of patients in their clinical trials with a high level of sensitivity and specificity, potentially accelerating clinical trials and increasing their chances for success.”
Patient data collected from this new service for clinical researchers along with additional planned clinical studies are expected to expand the database needed to obtain regulatory approval for the use of Chronix assays in ongoing cancer patient care.
Oral presentation: “Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer” (Abstract #10505)
June 7, 2010, 3:15 PM CT, Room S100a
About Chronix Biomedical (ASCO booth #6052)
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It is currently conducting studies in other cancers. The company initially plans to offer an Apoptotic Serum DNA testing service to cancer clinical researchers “For Investigational Use Only” to track disease recurrence and monitor treatment. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL TO LAUNCH CANCER DETECTION AND MONITORING SERVICE AT ASCO TO ADVANCE CLINICAL RESEARCH USING ITS APOPTOTIC DNA BLOOD TEST
—ASCO Data Show Chronix’s Apoptotic DNA Blood Test Detects Early-Stage Cancer with Excellent Sensitivity and Specificity—
—“For Investigational Use Only” Clinical Trial Service Is Designed to Provide Early Data on Patient Response and Disease Progression—Learn More at ASCO Booth #6052—
San Jose, CA, June 2, 2010 – Chronix Biomedical today announced that it will launch a new disease detection and monitoring service for cancer researchers at the upcoming 2010 ASCO Annual Meeting. The “For Investigational Use Only” laboratory-based testing service uses Chronix’s breakthrough approach—the Chronix Apoptotic DNA Blood Test—which analyzes apoptotic DNA from dead and dying cells to identify and track ongoing changes associated with specific cancers and other chronic diseases. Chronix’s proprietary blood test has been shown to accurately detect disease much sooner than other testing methodologies. The Chronix test also reports information that may have utility for selecting the best treatment for each patient. The new service will initially be offered to cancer researchers in the medical oncology and pharmaceutical research communities.
“Our laboratory-based testing service will enable cancer researchers for the first time to monitor the disease status of patients in their clinical trials with a high level of sensitivity and specificity using a simple blood test,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “In addition to our promising breast and prostate cancer data, our scientists are developing assays for other cancers. This new service provides us with a unique opportunity to aid cancer researchers while also expanding the database that will be needed to support the use of our assays in ongoing patient care.”
A growing body of peer-reviewed data shows that the Chronix blood test can detect cancer at the earliest stages. Chronix will present data at ASCO from a study of 575 individuals showing that it correctly identified the presence of prostate cancer or breast cancer with 92% sensitivity and 100% specificity, using the unique algorithms it has developed to detect and identify disease-specific DNA fragments in the blood from apoptotic cells. If confirmed in larger studies, these results would significantly outperform current diagnostic tests for these cancers. Chronix will discuss the breast and prostate cancer study results in an oral ASCO session on Monday, June 7 at 3:15 PM CT.*
The initial focus of the Chronix Apoptotic Serum DNA Testing Service is to offer researchers an affordable and reliable tool providing early information on the cancer status of patients in their clinical trials. In addition, because the Chronix technology can pinpoint specific DNA-related damage to the patient’s cells, this “personalized medicine” approach may make it possible to analyze each patient’s profile and then to match those profiles to treatment outcomes. These analyses could provide rapid feedback to researchers on the likely efficacy of treatment options and could potentially serve as surrogate biomarkers of the efficacy of different treatments.
The new Chronix laboratory service is supporting the work of Dr. Jean-Francois Boileau at the Odette Cancer Centre at Sunnybrook Health Services Centre in Toronto. Dr. Boileau, a surgical oncologist with the Centre’s Breast Care Team, has been an investigator for multiple breast cancer trials and is currently the Principal Investigator of a major foundation-funded study of the utility of sentinel node biopsy following neoadjuvant chemotherapy.
Dr. Boileau commented, “It is with great enthusiasm that we will be conducting studies aimed at validating the early results from the Chronix Apoptotic Serum DNA Testing Service, which has shown the ability to distinguish with great accuracy those women who have early breast cancer from those who do not. Also, we will be evaluating whether the Chronix test could be used to predict how different individuals will respond to different breast cancer treatments. We look forward to helping to verify whether the Chronix assay will prove to be an effective way to identify breast cancer at an early stage and if it could be useful in helping to tailor the individual’s therapy. The fact that this test can be run using a simple blood sample is a major advantage, and if these new studies validate the early findings, the Chronix approach could be a major contribution to the breast cancer field.”
Previously published studies have demonstrated that the Chronix technology can identify the presence or absence of active disease in multiple sclerosis patients and that it can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity. Commercial applications for veterinary use are in development with the University of Calgary, including a test for the early detection of BSE, or mad cow disease.
Learn More About This Groundbreaking Resource
Oncologists, health providers, drug developers and other organizations interested in learning how the Chronix Apoptotic Serum DNA Testing Service can positively impact their cancer clinical research can call (408) 960-2306 for more information, or email Chronix at info@chronixbiomedical.com.
Researchers are invited to visit the Chronix booth (#6052) at ASCO for further information.
*Abstract #10505, “Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer,” 3:15 PM CT, June 7, 2010, Room S100a
About Chronix Biomedical (ASCO booth #6052)
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It is currently conducting studies in other cancers. The company initially plans to offer an Apoptotic Serum DNA Testing Service to cancer clinical researchers “For Investigational Use Only” to track disease recurrence and monitor treatment. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX TO PRESENT DATA AT ASCO THAT COULD REVOLUTIONIZE THE DIAGNOSTIC PARADIGM FOR CANCER
-Serum DNA Blood Tests Detect Breast Cancer and Prostate Cancer with 92% Sensitivity and 100% Specificity in Data from 575 Individuals-
-Builds on Previous Positive Diagnostic Data in Cancer and Neurological Disorders-
-Chronix Biomedical to Launch Breakthrough Disease Detection and Monitoring Service for Clinical Researchers at ASCO-
San Jose, CA, May 21, 2010 – Chronix Biomedical today reported a summary of data supporting the utility of its serum DNA blood tests for the early and accurate detection of breast cancer and prostate cancer. The unique testing algorithms developed by Chronix detected and correctly identified DNA fragments in the blood from dying (apoptotic) cancer cells with 92% sensitivity and 100% specificity in both prostate cancer and breast cancer. If confirmed in larger studies, these results would significantly outperform those obtained from current diagnostics for these cancers. The new data, which were generated from 575 individuals, provide further evidence that Chronix’s proprietary serum DNA assays may represent a new diagnostic and prognostic platform that can identify cancer and other chronic diseases earlier and more accurately than is currently possible. The data will be presented in an oral session at the 2010 ASCO Annual Meeting on Monday, June 7 at 3:00 PM CT.*
“These early data suggest the Chronix assays have potential beyond the diagnostic tools available today in my specialty of breast cancer,” said Steven Narod, M.D., F.R.C.P.C., Director of the Familial Breast Cancer Research Unit at Women’s College Research Institute, an affiliate of the University of Toronto. “If these encouraging data hold up in further testing, this approach to cancer diagnostics and prognostics has the potential to change how we diagnose, monitor and manage many cancers. I am pleased to be working with Chronix to further validate these promising findings.”
A growing body of peer-reviewed data shows that the Chronix DNA-based blood tests can detect cancer recurrence at the earliest stages, and they also can provide insight into patient-specific response to treatment. Previous published studies have demonstrated their potential utility in breast cancer and multiple sclerosis. In conjunction with the University of Calgary, Chronix is also developing commercial applications for veterinary use, including tests for the early detection of BSE, or mad cow disease.
“With these encouraging findings, we are launching a ‘For Investigational Use Only’ laboratory-based testing service that for the first time will enable cancer researchers to monitor the status of patients in their clinical trials with a high level of sensitivity and specificity,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “This new service offers a unique opportunity to support clinical researchers while also expanding the database needed for regulatory approval for the use of our assays in ongoing patient care.”
Researchers are invited to visit the Chronix booth (#6052) at ASCO for further information and details.
*Abstract #10505, “Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer,” 3:15 PM CT, June 7, 2010, Room S100a.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast and prostate cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays to clinical researchers as a “For Investigational Use Only” test in its research laboratories. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL PARTNERS WITH UNIVERSITY OF CALGARY TO COMMERCIALIZE SERUM DNA-BASED BLOOD TEST FOR MAD COW DISEASE
-Canadian Grant Will Fund Development of a Cost-Effective, Commercial BSE Assay to Help Ensure the Safety of Beef-
-Published Studies have Demonstrated the Utility of Chronix’s Serum DNA Tests in Neurological Disorders and Cancer with Additional Cancer Data Selected for Presentation at ASCO-
San Jose, California, April 13, 2010 – Chronix Biomedical today announced that it is partnering with the University of Calgary to develop a commercial version of its serum DNA-based blood test for the early detection of bovine spongiform encephalopathy (BSE), also known as mad cow disease. Chronix researchers have published data demonstrating that the company’s proprietary techniques can accurately detect BSE in cattle before any disease symptoms are evident. Currently BSE can only be definitively diagnosed with a post-mortem brain biopsy. Development of the commercial BSE assay is supported by a grant from the Alberta Livestock and Meat Agency (ALMA) and Genome Canada. Chronix intends to begin offering BSE testing services to the cattle industry once the commercial test is finalized and validated.
Chronix’s technology identifies disease-specific genetic fingerprints based on circulating DNA that is released into the bloodstream by damaged and dying cells. The BSE test represents the first commercial application of Chronix’s technology, which is primarily being developed for the detection and monitoring of human diseases including cancer and chronic conditions. Chronix recently published studies showing that it can identify the presence or absence of active disease in multiple sclerosis patients and that its approach can accurately detect early stage breast cancer with high diagnostic sensitivity and specificity. Further validating the Chronix technology, researchers will disclose additional breast and prostate cancer study results in an upcoming oral presentation at the 2010 ASCO Annual Meeting.
“The technology from Chronix is the first to demonstrate the potential to achieve our goal of an accurate, cost-effective assay that will revolutionize BSE testing, making it economically and logistically feasible to screen all cattle in the food chain before BSE symptoms appear,” said Christoph Sensen, Ph.D., Professor at the University of Calgary Faculty of Medicine and Principal Investigator of the grant research program. “This effort is critically important because the risk of introducing BSE into the food chain continues to worry consumers and hinder international trade."
Chronix’s proprietary serum DNA blood tests are based on a growing body of publications showing that circulating DNA fragments can be identified and analyzed to provide a diagnostic window into changes associated with specific diseases. These changes can be used to track the presence of disease months or years before symptoms appear
Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix stated: “Our technology for the first time makes possible the early detection of BSE in an accurate, timely and cost-effective way. We appreciate the visionary support of ALMA and Genome Canada and look forward to working with our colleagues at the University of Calgary to develop a commercial BSE assay. Chronix is also currently developing additional serum DNA-based blood tests for human applications in cancer and chronic neurological conditions.”
BSE was among the first diseases that Chronix showed could be detected using its novel approach. In a 2009 publication in Nucleic Acids Research, scientists working with Chronix demonstrated that their blood test based on circulating DNA sequences could identify the presence of BSE and a related condition long before symptoms were evident.
ASCO abstract #10505: Comparative analysis of the chromosomal origins of circulating nucleic acids in breast and prostate cancer, June 7, 2010.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays in a CLIA laboratory setting. Chronix is headquartered in San Jose, California and has research facilities in Germany.
NEWLY PUBLISHED DATA SHOWS CHRONIX BIOMEDICAL’S SERUM DNA ASSAYS CAN MONITOR DISEASE ACTIVITY AND TREATMENT RESPONSE IN MULTIPLE SCLEROSIS
-New Study Published in Journal of Molecular Diagnostics-
-Follows Recent Publication Showing Utility of Chronix’s Serum DNA Tests in Breast Cancer-
San Jose, California, April 6, 2010 – Chronix Biomedical today announced publication of a study that supports the utility of its serum DNA blood tests to predict clinical status and monitor disease activity and response to treatment in multiple sclerosis (MS). Chronix Biomedical uses proprietary technology to identify disease-specific genetic fingerprints based on the circulating DNA that is released into the bloodstream by damaged and dying cells. A growing body of publications from Chronix and other researchers shows that this circulating DNA can be identified and analyzed to provide a diagnostic window into ongoing changes in the genome associated with specific diseases—changes that can be used to track the presence or absence of active disease. This new study is the first to show that the Chronix approach can be used to monitor the clinical status of a chronic disease. The findings are published in the current online edition of the Journal of Molecular Diagnostics.*
“These positive data further validate the premise underlying the Chronix approach, showing that the many genetic anomalies associated with active and stable relapsing-remitting MS can be detected by analyzing DNA fragments circulating in the blood serum,” said Mario Clerici, M.D., Chair of Immunology, Department of Biomedical Sciences and Technologies, University of Milano, Milan, Italy and a co-author of the study. “The prognostic value achieved in this study supports the ability of this new approach to help manage relapsing-remitting multiple sclerosis, potentially offering clinicians a new tool to easily assess which MS treatment options are most effective for their patients, as well as providing critical information that will facilitate development of the next generation of MS therapeutics."
In the study, researchers applied advanced analytical techniques developed by Chronix to identify genomic DNA fingerprints in the bloodstream of 28 MS patients known to have relapsing or stable disease as compared to 50 healthy volunteers. Researchers were able to distinguish the MS patients from the healthy volunteers and they also were able to use these circulating DNA fingerprints to differentiate periods of active disease attacks from the stable periods of disease remission characterizing relapsing-remitting MS, which affects about 85% of MS patients.
William M. Mitchell, M.D., Ph.D., Professor of Pathology at Vanderbilt University and a co-author of the study noted,” The data from this study suggests that the Chronix quantitative blood test provides a simpler, safer and more cost effective approach to assessing the activity of investigational new drugs for MS. Development of new MS drugs is currently complicated by the fact that disease status is monitored using dye-enhanced MRI scans that are expensive and are associated with occasional toxicities. In addition, they can only show neurological damage after it has occurred, while the Chronix approach provides a real time measure of disease activity.”
The newly published MS data follows earlier work that demonstrated the ability of Chronix’s serum DNA-based assays to diagnose mad cow disease and chronic wasting disease in live animals, conditions that until now could only be diagnosed using post-mortem biopsies. These successful studies in three neurological disorders suggest that when specialized nerve cells die, they leave behind unique DNA fingerprints characteristic of the cell of origin. Chronix researchers have figured out how to identify and apply these unique fingerprints to diagnose disease and monitor disease activity.
“These positive data further support the Chronix approach to detecting and monitoring diseases, including neurologic diseases such as MS,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “We are now preparing to offer laboratory testing services to support clinical trials for new neurologic drugs, initially focusing on MS and expanding to diseases such as Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease and autism. Eventually we intend to offer testing services that will allow physicians to monitor ongoing disease status and response to treatment in their patients with MS and other chronic neurological conditions.”
A publication in Molecular Cancer Research in March demonstrated the potential utility of the Chronix serum DNA assays in breast cancer. The findings demonstrated that the Chronix approach was able to detect invasive breast cancer with high diagnostic sensitivity and specificity, even at the earliest stage when tumors are very small.
Dr. Clerici is a member of the Chronix Medical Advisory Board and has an equity position in the company. Dr. Mitchell is an independent member of the Chronix Board of Directors and has an equity position in the company.
* “Serum DNA Motifs Predict Disease and Clinical Status in Multiple Sclerosis,” J Beck, H Urnovitz, M Saresella, D Caputo, M Clerici, M Mitchell, and E Schütz, J Mol Diag; 2010;12(5). Epub 12 Mar 2010.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays in a CLIA laboratory setting. Chronix is headquartered in San Jose, California and has research facilities in Germany.
NEWLY PUBLISHED DATA SHOWS CHRONIX BIOMEDICAL’S SERUM DNA ASSAYS CAN DETECT EARLY-STAGE BREAST CANCER
-Study in Molecular Cancer Research Shows Utility of Chronix’s Technology for Screening for Undiagnosed Breast Cancer and Monitoring of Cancer Recurrence-
San Jose, California, March 9, 2010 – Chronix Biomedical today announced publication of a study that supports the utility of its serum DNA blood tests for the early and accurate detection of breast cancer. The Chronix tests detect the circulating DNA that is released into the blood stream by damaged and dying cells. A growing body of publications from Chronix and other researchers shows that this circulating DNA can be identified and analyzed to provide a diagnostic window into ongoing changes in the genome associated with specific diseases—changes that can be used to identify disease processes at an early stage and to track responses to treatment. This new study shows that the Chronix approach was able to detect invasive breast cancer with high diagnostic sensitivity and specificity, even at the earliest stage when tumors are very small. The findings are published in the current online edition of Molecular Cancer Research.*
“This study supports the potential of an entirely new approach to identifying cancer at its earliest stages when therapies may be most effective,” said William M. Mitchell, M.D., Ph.D., Professor of Pathology at Vanderbilt University School of Medicine and a co-author of the study. “The promising diagnostic sensitivity and specificity achieved in this study further confirm the value of circulating DNA for disease detection and suggest that laboratory tests using this approach may have the potential both to screen large populations for cancer before symptoms appear and to monitor patients for the recurrence of cancer once treated.”
In the study, researchers applied advanced analytical techniques developed by Chronix to identify genomic DNA associated with breast cancer that was released into the bloodstream of women known to have breast cancer but was not present in healthy women or in patients with other medical conditions. Using the Chronix method, breast cancer was accurately detected at a diagnostic specificity level of 95% with a calculated sensitivity of 90%. Although not directly comparable, for reference it is useful to note that data from a large study of U.S. mammography screening programs reported an overall specificity of 92.3% and sensitivity of 75%, with lower figures for some populations such as younger women.
“These positive data further validate the premise underlying the Chronix approach, showing that DNA circulating in the serum can be used to detect disease at its earliest stages with high levels of accuracy,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “We have now been able to translate these research findings into a diagnostic assay that is initially suitable for use in clinical cancer research applications, and look forward to rapidly advancing both the breast cancer program and our pipeline of tests for other cancers and life threatening conditions.”
Dr. Mitchell is an independent member of the Chronix Board of Directors and has an equity position in the company.
* “Next Generation Sequencing of Serum Circulating Nucleic Acids from Patients with Invasive Ductal Breast Cancer Reveals Differences to Healthy and Nonmalignant Controls,” J Beck, H Urnovitz, WM Mitchell, and E Schütz, Mol Cancer Research; 2009;8(3):335-42. Epub 9 Mar 2010.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis, monitoring and management of a broad range of cancers and other conditions. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease, in breast cancer and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to offer its serum DNA-based assays in a CLIA laboratory setting. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL APPOINTS INDUSTRY VETERAN PAUL E. FREIMAN AS CHAIRMAN
-Broad Expertise will Help Advance Tests Based on Serum DNA for Early Detection and Management of Cancer-
San Jose, California, July 15, 2009 – Chronix Biomedical, an innovator developing blood tests based on serum DNA for the early detection and management of cancer, today announced that Paul E. Freiman has been appointed Chairman of the Board of Directors. Mr. Freiman, the former CEO of Syntex Corporation and Neurobiological Technologies, Inc., brings Chronix a wealth of pharmaceutical and biotechnology experience from his more than 30 years of successful industry leadership.
“Access to routine tests that can identify cancer at an early stage is high on the wish lists of many oncologists and now Chronix has the capability to make this possible,” said Mr. Freiman. “I see the future of excellent health care treatment as dependent on personalized medicine. Chronix’s technology, which identifies critical molecular diagnostic markers, will facilitate achievement of this goal. I look forward to helping to advance this important technology as the company seeks partners for further development and commercialization.”
Chronix has developed technology that makes it possible to diagnose cancer before symptoms appear, and it does so using simple blood tests that can be easily integrated into routine medical practice. Chronix’s innovative blood tests work by capturing information contained in DNA released into the blood stream by damaged and dying cells. This circulating DNA provides a window into ongoing changes in the genome associated with disease, changes that can identify a disease process at its earliest stages and help track response to treatment. The Chronix approach has recently been validated in a number of peer-reviewed articles.
As former Chairman and Chief Executive Officer of Syntex Corporation, Mr. Freiman is credited with much of the marketing success of Syntex’s blockbuster product, Naprosyn®, and was responsible for moving the product to over-the-counter status, where it is marketed as Aleve®. He also was instrumental in the sale of Syntex to Roche Holdings for $5.3 billion.
“Paul Freiman assuming the Chairman position at Chronix is a testament to the potential of our revolutionary serum DNA-based technology to transform the early diagnosis and management of cancer,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “Paul’s impressive record of biomedical industry leadership spans pharmaceuticals, diagnostics, biologics and public advocacy. We are fortunate to have the benefit of his broad experience and strategic counsel as we advance our technology through clinical validation toward commercialization.”
More recently, Mr. Freiman was President and Chief Executive Officer of Neurobiological Technologies, Inc. He also has extensive board experience, currently serving as Chairman of the Board of Penwest Pharmaceuticals Co., while also serving on the boards of Otsuka America Pharmaceuticals, Inc., NeoPharm Inc., and NovaBay Pharmaceuticals, Inc. Formerly, Mr. Freiman was Chairman of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) and has chaired a number of key PhRMA committees. He holds a B.S. degree from Fordham University and an honorary doctorate from the Arnold & Marie Schwartz College of Pharmacy and Health Sciences of Long Island University.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis and management of chronic diseases and cancer. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in a chronic neurologic disease and in multiple myeloma. It currently is conducting studies in other cancers. The company plans to collaborate with a variety of partners to develop and market its serum DNA-based assays that have the potential to transform the management of a broad range of cancers and other conditions. Chronix is headquartered in San Jose, California and has research facilities in Germany.
NEWLY PUBLISHED STUDY USING CHRONIX TECHNOLOGY CONFIRMS SERUM DNA CAN IDENTIFY THE EARLY PRESENCE OF DISEASE
-Study in Zoonoses & Public Health Further Illustrates the Potential Utility of Serum DNA for Diagnostic and Prognostic Applications-
San Jose, California, June 23, 2009 – Chronix Biomedical today reported that a new study in a peer-reviewed journal further confirms the potential diagnostic and prognostic utility of using circulating fragments of DNA to detect early stage disease. These DNA fragments, referred to as serum DNA, are released into the blood stream in trace amounts during the disease process. Chronix Biomedical has developed proprietary technology that can find, isolate and identify these serum DNA sequences, enabling very early detection of an underlying disease state or of a change in response to treatment. The study in the current issue of the journal Zoonoses & Public Health1 demonstrated that using Chronix technology, researchers were able to identify specific signature sequences in serum DNA before clinical symptoms appeared in animals experimentally infected with BSE (mad cow disease).
“These new results add to the growing body of scientific data validating the value of serum DNA as an early indicator of disease, and also advance our unique ability to apply these findings to the development of laboratory tests for routine clinical use,” said Howard Urnovitz, Ph.D., CEO of Chronix. “Using our proprietary technology and next-generation sequencers, we were able to identify distinctive DNA signatures indicating the presence of BSE in all of the infected animals well before clinical symptoms appeared.”
These new findings follow three previous published studies demonstrating the utility of using serum DNA to identify human cancers, human infectious disease and BSE. For example, a study reported in the December issue of the journal Blood showed that serum DNA was able to identify a secondary cancer in a patient before it was clinically apparent.
Of special interest in this current study is the finding that these DNA signatures occurred primarily in non-coding regions of the genome, where geneticists typically would not look. Chronix scientists believe these findings may lead to a better understanding of the genetics of disease development, while advancing Chronix’s own ability to harness these early changes for diagnostic and prognostic applications.
1. Beck, J., Urnovitz, H., Groschup, M., Ziegler, U., Brenig, B., Schutz, E. (2009) Serum Nucleic Acids in an Experimental Bovine Transmissible Spongiform Encephalopathy Model. Zoonoses and Public Health. (Published Online May 20, 2009).
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis and management of chronic diseases and cancer. It has developed proprietary technology that measures and categorizes DNA sequences circulating in the serum that are associated with specific changes in disease and health status. Using advanced genome analysis methodology, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in multiple myeloma and mad cow disease, and studies in other diseases are underway. The company plans to collaborate with a variety of partners to develop and market its serum DNA-based assays that have the potential to transform the management of a broad range of cancers and other conditions. Chronix is headquartered in San Jose, California and has research facilities in Germany.
CHRONIX BIOMEDICAL SAYS THREE RECENT STUDIES SUPPORT THE UTILITY OF CIRCULATING DNA AS NOVEL DIAGNOSTICS FOR HUMAN CANCER, MAD COW DISEASE AND OTHER CONDITIONS
-Study in Clinical Chemistry Demonstrates Feasibility of Identifying and Categorizing Circulating Nucleic Acids-
-Studies in Nucleic Acids Research and Blood Support Potential Diagnostic Applications in Mad Cow Disease and Human Cancer-
San Jose, California, March 10, 2009 – Chronix Biomedical - developing and applying proprietary techniques to detect and analyze circulating nucleic acid sequences for the diagnosis and management of disease - today reported that three recent studies published in peer-reviewed journals have further confirmed the potential diagnostic and prognostic utility of fragments of DNA and RNA that circulate in the blood, known as circulating nucleic acids (CNAs). Data from these studies confirm previous findings showing that CNAs can identify the presence of certain diseases in blood samples months to years before clinical symptoms appear.
“The recent publication of these three studies represents a major milestone in the recognition of CNAs as novel diagnostic tools,” said Howard Urnovitz, Ph.D., CEO of Chronix. “Our ability to accurately identify and characterize the presence of significant differences in CNA levels and sequences between healthy and diseased individuals demonstrates how CNAs would be used for diagnosis and disease management in conditions as diverse as bovine spongiform encephalopathy (mad cow disease) and human cancers.”
In the study appearing in the current online edition of Clinical Chemistry, scientists from Chronix applied ultra-high speed sequencing technology and proprietary data analysis tools to characterize and categorize the CNA markers present in multiple individuals. The resulting databases of CNAs associated with specific disease states can be used to identify persons with undiagnosed disease, and potentially, to track changes in disease status. For example, the study found that one of the presumed healthy volunteers was actually infected with hepatitis B.
This study follows publication in January of research from scientists at the University of Calgary, Canada, the University of Göttingen, Germany and Chronix showing the ability of a simple blood test based on circulating DNA sequences to identify the presence of bovine spongiform encephalopathy (BSE) and the related condition chronic wasting disease (CWD) in live animals long before symptoms were evident. This advance is especially significant since BSE can now only be confirmed by examining the brain tissue of dead animals. Following expected confirmation in larger studies, this new approach could revolutionize testing for BSE, making it economically and logistically feasible to screen all cattle in the food chain before BSE symptoms appear. The study was published in the journal Nucleic Acids Research.
A third reported study highlights the potential utility of CNAs in the management of cancer. Dr. Urnovitz, and Brian G.M. Durie, M.D., Medical Director and co-founder of the International Myeloma Foundation, identified specific DNA sequences circulating in the blood of a patient with the bone marrow cancer multiple myeloma and tracked variations in these sequences as the patient’s myeloma moved in and out of remission. There was also an unexpected finding when CNAs identified the development of a secondary cancer in this patient, before it was clinically apparent. This preliminary study is significant because it shows that CNAs can potentially be used to diagnose, monitor and manage cancer treatment. The abstract reporting this data was published in the journal Blood in connection with the December 2008 meeting of the American Society of Hematology.
“This approach opens the door to a new tool that will enable us to follow the progress of cancer treatment and give us an early warning when a myeloma patient is about to come out of remission,” said Dr. Durie. “This will allow us to stay ahead of the disease instead of waiting for the patient to get sick before we can act. That capability will represent a major change in the way we treat this cancer.”
Dr. Urnovitz concluded, “Even in these experiments we found unexpected results – undiagnosed hepatitis in one patient and a secondary cancer in another – confirming the utility of CNAs in finding unsuspected disease. With these multiple proof-of-concept experiments now completed, we are embarking on the studies needed to further confirm and commercialize this powerful new approach with important applications in personalized medicine and human health.”
Chronix intends to work with a number of industry partners to develop and commercialize its CNA technology for diagnostic and prognostic applications. These emerging markets for novel genetic-based assays have multi-billion dollar potential. Because the Chronix technology can identify early changes in disease status, it also can be used to generate surrogate measures for drug development studies aimed at distinguishing responder and non-responder patient subgroups. The company has recently initiated discussions with potential pharmaceutical partners.
About Chronix Biomedical
Chronix Biomedical is pioneering a breakthrough approach to the diagnosis and management of chronic diseases and cancer. It has developed proprietary technology that measures and categorizes circulating nucleic acids, DNA sequences circulating in the blood that are associated with specific changes in disease and health status. Using advanced genome analysis methods, proprietary data tools and disease-specific databases, Chronix has demonstrated the utility of its diagnostic and prognostic approach in mad cow disease and multiple myeloma, and studies in other diseases are underway. The company plans to collaborate with a variety of partners to develop and market its DNA-based assays that have the potential to transform the management of a broad range of cancers and other conditions. Chronix is headquartered in San Jose, California and has research facilities in Germany.
Phone: 408-960-2306 | Email: info@chronixbiomedical.com
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Publication
Journal of Molecular Diagnostics, 2010
Serum DNA Motifs Predict Disease and Clinical Status in Multiple Sclerosis
Molecular Cancer Research, 2010
Published results show utility of Chronix's technology in Breast Cancer
Zoonoses and Public Health, 2009
Published results show the detection of a novel quiescent parvovirus infection in experimental cattle
Clinical Chemistry, March 2009
Published study in presumed healthy volunteers: serum DNA indicated one of the volunteers was actually infected with hepatitis B
Nucleic Acid Research
Published study validated serum DNA approach in BSE and Chronic Wasting Disease in Elk
Blood, November 2008
Published abstract demonstrates results in multiple myeloma patient: serum DNA identified the development of a secondary cancer before it was clinically apparent
Chronix in the News
In Sequence, March 31, 2009
Cell-Free DNA, RNA May Hold Key to New Diagnostics, Chronix Biomedical Says
Medical Device Daily, March 19, 2009
Chronix breakthroughs to yield new 'routine' diagnostic tests
Scientific American, March 18, 2009
DNA on the Loose: Next-Gen Blood Tests Tap Free-Floating Genetic Material
In Sequence, March 17, 2009
California Startup Publishes Data on Circulating Nucleic Acids; Seeks Partners
DowJones VentureWire & DowJones VentureWire Lifescience, March 12, 2009
Chronix Leaves Stealth, Launches Series C Hunt
VentureBeat, March 12, 2009
Diagnostics firm Chronix busts out of stealth, looks for cash
BioWorld Today, March 10, 2009
With Advances In Genomics, Exosomes Broaden Horizons
GenomeWeb Daily News, March 10, 2009
California Startup Publishes Data on MDx Technology; Seeks Partners
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