AsianScientist (Feb. 16, 2012) – Affymetrix, Inc. today announced that its GeneChip® System 3000Dx v.2 (GCS 3000Dx v.2) has been approved by China’s State Food and Drug Administration (SFDA) for in vitro diagnostic use.
It represents the first microarray instrument system to be granted SFDA clearance for in vitro diagnostics, and more than 2,000 clinical centers in China will now have access to the platform.
The molecular diagnostic market in China is the fastest growing in the world and represents a significant growth opportunity for Affymetrix in Asia, the company said in a press statement.
“We are delighted to be the first SFDA-cleared microarray platform, as this will enable us to expand into the clinical diagnostics applications,” said Chris Barbazette, Vice President, Commercial Operations International Markets at Affymetrix.
The GCS 3000Dx v.2 microarray system has been cleared for in vitro diagnostic use in the United States, Japan, CE-IVD marked in Europe, and in Canada, Singapore, Australia, India, and Saudi Arabia.
Via the Powered by Affymetrix™ program, a number of companies are developing molecular diagnostic tests in cancer, cardiovascular diseases, and inherited disorders based on the Affymetrix GeneChip platform.
More than ten tests are in the pipeline for regulatory clearance, and two FDA-cleared tests (Roche AmpliChip® CYP450 Test and Pathwork® Diagnostics’ Tissue of Origin Test) and three CE-IVD marked tests, including Skyline Diagnostic’s AML test, are currently on the market.
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Source: Affymetrix, Inc.
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