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FDA Clears Affymetrix Gene Profiling Reagents

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Affymetrix today announced the US Food and Drug Administration has cleared its Gene Profiling Reagents as accessories to the GeneChip Microarray Instrument System for in vitro diagnostic use.

The clearance of the gene expression reagents makes the company the first to provide a "comprehensive microarray-based clinical toolkit for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives," the firm said. It added that use of the reagents should lead to more consistent results and lower commercialization costs for clinical providers and other Affy customers.

Affy said that companies such as Roche and Skyline Diagnostics have developed tests on its gene expression instrument platform that have either already been cleared by regulators, such as FDA, or are in the process of being submitted for clearance.

"Thousands of research customers and Powered by Affymetrix Partners use our research products every day to identify signatures or expression patterns that may lead to a cancer diagnostic or an improved therapy determination for patients," Affymetrix President and CEO Kevin King said in a statement. "These customers can now seamlessly migrate from basic signature discovery to validation on a robust system."

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