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Caris Diagnostics Launches Target GI(TM) for Colon Cancer Patients

August 11, 2008

IRVING, Texas and PHOENIX, Aug. 11 /PRNewswire/ — Caris Diagnostics (Caris Dx), a leading provider of the highest quality diagnostic, translational development and pharmaceutical services encompassing anatomic pathology and molecular testing, announced today the offering of Target GI to physicians nationwide. Target GI is designed to provide information on the expression of key molecular targets present in colon cancer, providing physicians the most up-to-date information to help in the management of their patients.

The Target GI test includes analysis of a key group of biomarkers that have been identified as relevant in clinical studies on colon cancer. These biomarkers include KRAS (Proto-oncogene of the Kirsten murine sarcoma virus) by mutational analysis and TS (thymidylate synthase) and TOPO1 (topoisomerase 1) by immunohistochemical analysis.

Patient tumors that have somatic mutations in KRAS have been associated with a lack of response to cetuximab and panitumumab. Patients with metastatic colorectal cancer over-expressing TS have been shown to have a lower response to fluorouracil chemotherapy and shorter disease-free survival. Additionally, high expression of TOPO1 has been associated with an overall survival benefit with first line combination chemotherapy that includes irinotecan.

“It is a key initiative for us to not only provide highly accurate diagnostic information to clinicians, but also take the next step and offer additional information to assist in their treatment and management decisions,” commented Richard Lash, M.D., Chief Medical Officer of Caris Dx. “Target GI enhances our leading position in gastrointestinal pathology.”

Currently Caris Dx receives, processes, and interprets over ten thousand GI biopsies each week. The Target GI assay allows molecular profiling to be performed on those qualifying biopsies, without the need for additional coordination, delay in treatment, or specialist referral, while developing a direct partnership with the gastroenterologist and oncologist for the benefit of the patient.

“With our ability to perform the Target GI analysis on the biopsies that we receive for initial cancer diagnosis each week, the paths of anatomic pathology and molecular testing are now united in a highly efficient manner. We can offer critical, additional information to physicians and their patients before beginning a course of treatment that includes relevant chemotherapy,” concluded David D. Halbert, Chairman of Caris Dx.

Target GI, intended to be performed on the initial biopsy upon the diagnosis of colon cancer, is being offered as a complement to the Caris Dx Target Now(TM) program. Target Now is designed to provide molecular profiling information on a patient’s tumor after standard treatments have been tried or if they are not available as an aid to their treating oncologist regarding future therapy decisions.

Physicians can obtain more information or order Target GI or Target Now for their patients by contacting 1-800-901-5177.

About Caris Diagnostics

Caris Diagnostics (Caris Dx) is a leading provider of the highest quality diagnostic, translational development and pharmaceutical services encompassing anatomic pathology and molecular testing. Caris Diagnostics provides world-class pathology services to physicians who treat patients in the community setting. The company provides academic-caliber medical consults through its industry-leading team of subspecialty fellowship and expert-trained pathologists in gastrointestinal and liver pathology, dermatopathology and hematopathology. Caris Diagnostics provides the highest levels of service to its customers and their patients through its state-of- the-art laboratories; proprietary, advanced clinical and technology solutions; and rigorous quality assurance programs. Through the molecular testing expertise of the Caris Molecular Profiling Institute (Caris MPI) at Caris Dx, the company also offers advanced molecular analyses of patient samples through prognostic testing services and genomic and proteomic profiling to provide critical information to physicians treating cancer and other complex diseases. In addition, Caris MPI supports pharmaceutical companies and other researchers in their clinical trials for targeted therapeutics with custom genomic and proteomic analyses, analyte preservation, tissue procurement and comprehensive reporting services. The company has strategic relationships with the International Genomics Consortium, US Oncology, the Translational Genomics Research Institute, and the Biodesign Institute of Arizona State University. More than 2,000 physicians nationally use Caris Diagnostics. Formed in 1996, the company is headquartered in Irving, Texas and operates four laboratories: Irving, Texas; Phoenix, Arizona (2 sites); Newton, Massachusetts. Additional information is available at http://www.carisdx.com/.

Caris Diagnostics

CONTACT: Leslie Brille, +1-212-521-4444, for Caris Diagnostics

Web site: http://www.carisdx.com/




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