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FDA Approves Pathwork Tissue of Origin Test to Identify Cancer Cells in Tumors

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A test that helps identify the type of cancer cells present in a tumor has been approved by the U.S. Food and Drug Administration.

The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic data stored in a database from evaluated cancers. The test, which is able to analyze thousands of pieces of genetic material at a time, considers 15 common cancer types, including those of the bladder, breast, and colon.

"The clearance of the Pathwork test is another step in the continued integration of molecular-based medicine into standard practice," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

The test and its technology are produced by Pathwork Diagnostics of Sunnyvale, Calif., and Affymetrix Inc., of Santa Clara, Calif.

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