Press Releases
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.
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.
-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.
-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.
-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
Content copyright . Chronix Biomedical. All rights reserved.
Publication
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
Back to TopClinical Chemistry, March 2009
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
Back to TopClinical Chemistry, March 2009
