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Affymetrix Inc.’s product for in vitro gene expression diagnostic testing has been given regulatory clearance by the U.S. Food and Drug Administration, the company said Thursday.

Santa Clara-based (NASDAQ:AFFX) said the microarray system was granted clearance along with the Pathwork Tissue of Origin Test from Sunnyvale-based Pathwork Diagnostics Inc., which analyzes a tumor’s gene expression profile to aid in diagnosing the source of hard-to-identify tumors.

Pathwork is a member of the Powered by Affymetrix program, which includes 11 leading diagnostic companies.

"Together Affymetrix and Pathwork have developed and now bring to market a very powerful tool to potentially improve cancer diagnostics and subsequent treatment planning and outcome," said Kevin King, president of Affymetrix credit reports. "The Pathwork Tissue of Origin Test is supported by extensive analytical and clinical validation data. This not only expands the menu on our diagnostic platform, but opens the door for other gene expression-based diagnostic tests that are currently being developed by Affymetrix and our PbA partners on the GCSDx platform."