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Affymetrix Inc. (AFFX) Receives FDA Clearance for Gene Expression Technology

Affymetrix Inc. yesterday announced it has received U.S. Food and Drug Administration clearance for the addition of new gene expression reagents as accessories to the company’s GeneChip® Microarray Instrument System for in vitro diagnostic (IVD) use, positioning Affymetrix as the first company in the industry to provide a comprehensive microarray-based clinical toolkit for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives.

The Affymetrix gene expression platform is a comprehensive system used for enabling the development of clinical diagnostic tests. The company said the technology was designed to reduce development time by easing the regulatory burden and delivering reproducible results.

“Affymetrix created the technology and marketplace for multiplexed gene expression more than a decade ago, and this clearance of our gene profiling reagent kit by the FDA marks another milestone in our leadership in this important market segment,” Kevin King, president and CEO of Affymetrix stated in the press release.

King noted that Affymetrix’s products are used by thousands of research customers and powered by Affymetrix™ (PbA) partners, which use its research products on a daily basis to identify signatures or expression patterns that may lead to a cancer diagnostic or an improved therapy determination for patients.

“These customers can now seamlessly migrate from basic signature discovery to validation on a robust system,” he said.

The company also highlighted its operations and its position in the healthcare industry.

“Customers who are commercializing products on the Affymetrix clinical platform can rely on our proven technology, global distribution, services, and support organization,” said Affymetrix chief commercial officer Andy Last. “Affymetrix is leading the industry into the era of personalized medicine by turning our knowledge about biology, genes, and disease into tangible clinical applications, and ultimately, into diagnostic decisions that improve quality of life.”

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