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Chronix Biomedical Adds State-of-the-Art Mass Sequencing Capabilities to Accelerate Development of Its DNA Biomarkers for Early Detection of Cancer


8/17/2010 9:11:13 AM

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 ABI 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

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 is now offering its Apoptotic Serum DNA testing service to cancer researchers “For Investigational Use Only” to track disease recurrence and monitor treatment in clinical trials. Chronix is headquartered in San Jose, California and has research facilities in Germany. For more information, visit www.chronixbiomedical.com.

Barbara Lindheim GendeLLindheim BioCom Partners LLC 48 Wall Street, suite 1100 New York, NY 10005 212.918.4650 (office) 917.355.9234 (mobile) www.biocompartners.com



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