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SFDA approves Affymetrix microarray platform

China's State Food and Drug Administration (SFDA) has approved Affymetrix's GeneChip System 3000Dx v.2 (GCS 3000Dx v.2) for in vitro diagnostic use.

Affymetrix said its GCS 3000Dx v.2 microarray platform has been developed and commercialized through partnership via the Powered by Affymetrix (PbA) program.

Based on the company’s GeneChip platform many companies are developing molecular diagnostic tests in cancer, cardiovascular diseases, and inherited disorders.

Roche AmpliChip CYP450 test and Pathwork Diagnostics’ Tissue of Origin test, which are developed based on GeneChip, are FDA cleared and three CE-IVD marked tests including Skyline Diagnostic’s AML test, are available in the market.

Hangzhou Bio-San Biochemical Technologies Company Ming Zhang said having an SFDA-cleared system and a wide-range of clinical tests will enable physicians in China to bring personalized medicine to their patients faster.

Affymetrix Genetic Analysis and Clinical Applications business unit executive vice president Andy Last said with the clearance of GeneChip System, it connects them more closely to physicians in China wanting to utilize clinically relevant genomic biomarkers that improve their patients’ health and wellness.