Affymetrix Inc. announced that the US 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 Tissue of Origin (TOO) Test from Pathwork Diagnostics Inc. This test analyzes a tumour's gene expression profile to aid in diagnosing the source of hard-to-identify tumours and is the first of its kind to receive FDA clearance.

Pathwork is a member of the Powered by Affymetrix (PbA) programme, which includes 11 leading diagnostic companies. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its PbA Partners.

"We decided to work with Affymetrix because it is the market leader in gene expression testing research and its 510(k)-cleared microarray platform enabled us to develop a robust diagnostic," said Deborah J. Neff, president and chief executive officer of Pathwork Diagnostics. "The FDA's clearance of the Pathwork Tissue of Origin Test reaffirms the importance of genomics and the role microarray-based diagnostics can play in the battle against cancer."

"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. "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."

Affymetrix is headquartered in Santa Clara, California, and has manufacturing facilities in Sacramento, California, Cleveland, Ohio, and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia.