Newly Published Data Shows Chronix Biomedical's Serum DNA Assays Can Detect Early-Stage Breast Cancer

posted - MAR 09, 2010

News source: Business Wire

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.


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