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FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
Date:7/31/2008

xpression patterns of a panel of 15 known tumor types, representing 60 morphologies overall, to help determine the tumor's origin. In the in vitro diagnostics clinical validation study submitted to the FDA, the test demonstrated 89 percent positive agreement (akin to sensitivity) with available diagnoses and 99 percent negative agreement (akin to specificity). The study consisted of 545 metastatic, poorly differentiated and undifferentiated tumors that had been identified as one of the 15 tumor types on the panel using existing methods.(5) The test demonstrated an average 94 percent overall concordance across four laboratories in a cross-laboratory comparison study of 60 metastatic, poorly differentiated and undifferentiated tissue specimens.(6)

"Hard-to-identify tumors are a significant clinical problem," said Dr. James Abbruzzese, Professor of Medicine at M.D. Anderson Cancer Center. "They are time-consuming and frustrating for both physicians and patients. Accurately identifying a tumor's origin -- and thus knowing what kind of cancer the patient has -- is necessary for beginning standard-of-care, cancer-specific treatment per the National Comprehensive Cancer Network Clinical Practice Guidelines. Knowing the tumor's origin can also enable patients to get into -- and benefit from -- appropriate clinical trials."

Targeted cancer therapies can be effective even with metastatic tumors and are generally tumor-specific (e.g., Herceptin(R) for breast cancer), requiring identification of the primary tumor site or tissue of origin. Targeting therapy to specific tumor types can allow patients to avoid the toxicity of broader chemotherapy.

"Traditional tools used to identify tumors of uncertain origin include imaging studies, such as CT scans and MRIs, as well as a thorough pathological evaluation with immunohistochemistry and other techniques," said Federico Monzon, M.D., Director of Molecular Diagnostics of The Methodist Hospital in Houston. "However
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SOURCE Pathwork Diagnostics, Inc.
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