FDA Clears the Pathwork Tissue of Origin Test for Hard-To-Identify Tumors

Pathwork Diagnostics, Inc., a molecular diagnostics company focused on oncology, 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...

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