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Clarient to Commercialize Novel Breast Cancer Profile
Date:1/9/2008

t our strong cancer-focused brand, support and loyalty among community pathologists and our unique, Internet-based PATHSiTE(TM) delivery system will drive market acceptance for this exciting test."

The new breast cancer profile has undergone rigorous validation. The results to date show excellent accuracy and substantial out-performance of standard treatment guidelines. As preparations are made for full market launch in 2008, the companies will continue to generate clinical data designed to further expand the established indications and to comply with future regulatory requirements. The companies believe that Clarient's Insight Dx Breast Cancer Profile fits the description of a lab-developed test according to the current regulatory guidelines. Should the FDA adopt proposed guidance to regulate certain lab-developed tests, the companies intend to submit the required documentation for clearance within the timeframe provided.

"Clarient currently performs approximately 20 percent of all breast cancer prognostic work-ups in the U.S.," Andrews continued. "We are extremely proud of the brand we have developed in such a short period in the area of breast cancer, and the availability of this high-value test could improve patient care and decrease the economic burden on the healthcare system."

About Prediction Sciences

Based in La Jolla, California, Prediction Sciences develops high-value molecular diagnostics and assays for disease detection, prognosis, and treatment outcome prediction under their trademarked brand names, RapidResponse(TM) and GeneRx(TM). Prediction Sciences has a deep diagnostics pipeline, with lead candidates that address critical unmet clinical needs in oncology and stroke. Prediction Sciences is committed to improving the safety and efficacy of disease treatments, and their diagnostic tests are making personalized medicine a reality. http://www.predict.net

About Clarien
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SOURCE Clarient
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