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Affymetrix Inc.
Affymetrix Microarray Platform Granted Clearance from FDA for Gene Expression Diagnostic Testing
August 22nd, 2008
Affymetrix Inc. (Nasdaq:AFFX) announced 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. Pathwork is a member of the Powered by Affymetrix(TM) (PbA) program, which includes 11 leading diagnostic companies. There are currently more than 20 different molecular assay...
Source: Health Business Week (2008-08-22)
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