FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Ident...( Pathwork Diagnostics' Gene Express...),Health

Pathwork Diagnostics' Gene Expression Test Is the First to Receive FDA Clearance for Diagnosis of Uncertain Tumors; Problem Affects 200,000 New

U.S. Cancer Cases Annually

SUNNYVALE, Calif., July 31 /PRNewswire/ -- Pathwork Diagnostics, Inc., a molecular diagnostics company focused on oncology, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Pathwork(R) Tissue of Origin Test for use in determining the origin of uncertain tumors. The test analyzes a tumor's gene expression pattern to help pinpoint the source of hard-to-identify tumors and is the first test of its kind to receive FDA clearance. Up to an estimated 200,000 newly diagnosed cancer patients annually in the U.S. may have a tumor for which the site of origin is uncertain after the initial diagnostic workup.(1,2,3,4) The FDA's clearance underscores the growing role that patients' genomic information can play in helping physicians make better decisions.

"Knowing the primary tumor site with greater certainty enables more appropriate cancer treatment. The growing trend in cancer care is the use of therapies that target specific tissues and their genomic components, rather than relying on a one-size-fits-all treatment approach," said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics. "We believe the Pathwork Tissue of Origin Test will help provide more certainty in tumor diagnosis, which will enable more patients to realize the benefits of this new era in genomics-based diagnostics." The FDA-cleared Pathwork Tissue of Origin Test will be available as an in vitro diagnostic (IVD) kit, meaning that clinical laboratories can run the test themselves. The test is currently available as a service through Pathwork's CLIA-certified laboratory.

The Pathwork Tissue of Origin Test uses a microarray to measure the expression pattern, comprising more than 1,500 genes, in the uncertain tumor and compares it to e
'/>"/>