Pathwork Diagnostics Launches Version of Its Tissue of Origin Test for FFPE...( New Version Increases Physician Acces...),Health

New Version Increases Physician Access

SUNNYVALE, Calif., Jan. 13 /PRNewswire/ -- Pathwork Diagnostics, Inc., launched today an additional version of the Pathwork(R) Tissue of Origin Test that has the capability of analyzing formalin-fixed, paraffin-embedded (FFPE) tissue specimens. This molecular diagnostic test, which aids in the diagnosis of tumors with uncertain origins, is now available as a service through the CLIA-certified Pathwork Diagnostics Laboratory.

"The capability to work with FFPE specimens will enable our test to be more broadly utilized by oncologists and pathologists," said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics. "Due to the RNA degradation that occurs in FFPE specimens, generating robust and reproducible data for many genes simultaneously was a significant challenge. Maintaining the high level of robust and reliable performance for the FFPE version of the test was an outstanding technical accomplishment by the company."

To determine the tumor's origin, the Pathwork Tissue of Origin Test uses microarray technology to measure the expression pattern, comprising more than 1,500 genes, in a tumor with an uncertain origin and compares it to expression patterns of a panel of 15 known tumor types, representing 90 percent of all solid tumors and 58 morphologies overall. In the clinical validation study utilizing FFPE tumor specimens, the test demonstrated 89% positive percent agreement (akin to sensitivity) with available diagnoses and greater than 99% negative percent agreement (akin to specificity).(1) This statistically significant study consisted of 352 metastatic, poorly differentiated and undifferentiated tumors that had been identified as one of the 15 tumor types on the panel using existing methods.

The American Cancer Society estimates that there are 1.4 million new cancer diagnoses annually in the United States. Of these new cas
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