Pathwork(R) Diagnostics Launches Genomics-Based Test For Hard-To-Identify Tumors Through Its CLIA-Certified ...( The Pathwork(R) Tissue of Origin Te...)

The Pathwork(R) Tissue of Origin Test Aids in the Diagnosis of Uncertain

Tumors

SUNNYVALE, Calif., April 22 /PRNewswire/ -- Pathwork Diagnostics, Inc., a genomics-based diagnostics company focused on oncology, today announced the launch of the Pathwork Tissue of Origin Test through its CLIA-certified Pathwork(R) Diagnostics Laboratory. The new test aids in the diagnosis of tumors of uncertain origin and is among the first microarray-based diagnostic tests for cancer available in the United States.

"The Pathwork Tissue of Origin Test uses the power of genomic information to provide diagnostic answers that help physicians make clinical decisions with more certainty. Ultimately, we believe our test will improve patient outcomes while saving the healthcare system money," said Deborah J. Neff, president and chief executive officer of Pathwork Diagnostics. "We are making our test available through our clinical laboratory due to strong interest from leading oncologists and pathologists. We are also working actively with the FDA to obtain product clearance, so that we can offer a diagnostic kit directly to clinical laboratories at major medical centers."

The Pathwork Tissue of Origin Test measures the expression of more than 1,500 genes to compare a tumor's gene expression profile to those of 15 known tissues, representing more than 60 morphologies, and to provide an objective, probability-based score for each potential tissue. The test uses a proprietary Pathchip(TM) microarray and runs on the proven Affymetrix GeneChip(R) System. In a Pathwork Diagnostics Laboratory clinical validation study of 487 metastatic and poorly differentiated and undifferentiated tumors, which had already been identified using current methodologies, the test demonstrated a sensitivity of 89 percent and a specificity of 99 percent.(1)

"Hard-to-identify tumors are a significant clinical problem," said Divyesh D. Mehta, M.D., Dire
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