Affymetrix Microarray Platform Granted Clearance from FDA for Gene Expression Diagnostic Testing

Affymetrix Inc. (Nasdaq:AFFX) announced today that the U.S. Food and Drug Administration (FDA) has granted regulatory clearance to its GCS3000Dx (GCSDx) platform for in vitro gene expression diagnostic testing. The microarray system was granted clearance along with the Pathwork(R) Tissue of Origin (TOO) Test from Pathwork Diagnostics Inc. This test analyzes a tumor’s gene expression profile to aid in diagnosing the source of hard-to-identify tumors and is the first of its kind to receive FDA clearance.

Source: Affymetrix, Inc.