Affymetrix, Inc. (NASDAQ:AFFX) 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. The GCS 3000Dx v.2 is the first microarray instrument system to be granted SFDA registration for array-based diagnostics for enabling personalized medicine. China has more than 2,000 clinical centers that will now have access to the only SFDA-cleared microarray platform for clinical testing.
The molecular diagnostic market in China is the fastest growing in the world and represents a significant growth opportunity for Affymetrix in Asia. "We are delighted to be the first SFDA-cleared microarray platform, as this will enable us to expand into the clinical diagnostics applications," says Chris Barbazette, Vice President, Commercial Operations International Markets at Affymetrix.
The GCS 3000Dx v.2 microarray platform has a proven record of successful development and commercialization through partnership via the Powered by Affymetrix™ (PbA) 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. 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. These tests and Affymetrix' own solutions for cytogenetics, cancer, and pharmacogenomics are part of an increasing menu of clinical applications that can be run on the SFDA-cleared GeneChip System.
"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," says Dr. Ming Zhang at Hangzhou Bio-San Biochemical Technologies Company.
"This registration clearance is a significant accomplishment for Affymetrix and supports our global clinical strategy. It connects us more closely to physicians in China wanting to utilize clinically relevant genomic biomarkers that improve their patients' health and wellness," said Andy Last, Executive Vice President of Genetic Analysis and Clinical Applications Business Unit at Affymetrix.
The GCS 3000Dx v.2 microarray System is cleared for in vitro diagnostic use in the United States, Japan, CE-IVD marked in Europe, and is also available in Canada, Singapore, Australia, India, and Saudi Arabia.
In addition to the GCS 3000Dx v.2, Affymetrix also offers a Clinical Toolkit, which contains the US FDA-cleared and CE-IVD marked Gene Profiling Reagents and the Gene Profiling Array cGMP U133 P2, the cGMP-manufactured version of the widely cited GeneChip® Human Genome U133 Plus 2.0 Array. The Affymetrix® Clinical Toolkit provides a proven path to market, enabling test developers to save time and money while reducing regulatory risks.