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FDA Clears Affymetrix Gene Expression Reagents for IVD Use

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Affymetrix this week said that the US Food and Drug Administration has cleared its Gene Profiling Reagents as accessories to its GeneChip microarray instrument system for in vitro diagnostic use.

The Santa Clara, Calif.-based life science tools vendor now claims to be the "first in the industry" to offer array-based tools for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives.

It also said the use of the cleared reagents for clinical test development should lead to "more consistent results and lower commercialization costs for clinical providers and other Affymetrix customers."

CEO Kevin King in a statement called the clearance of the reagents a "milestone" for the firm in the molecular diagnostics market.

"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," King said. These customers can now "migrate from basic signature discovery to validation" on the firm's platform, he said.

Over a dozen companies are members of Affy's Powered by Affymetrix program. Program membership allows participants to develop and bring tests to market on the company's array platform. A number of partners, including Roche, Pathwork Diagnostics, and Skyline Diagnostics have already had their tests cleared by American and European regulatory authorities for clinical use (BAN 3/15/2011).

Affy last year filed a 510(k) submission with the FDA for "reagents to be used in conjunction" with the company's Human U133 Plus 2.0 expression array (BAN 11/2/2010).

Now manufactured under Good Manufacturing Processes and International Organization for Standardization guidelines, Affy has rebranded the U133 as the Gene Profiling Array. This week, Affy said that the newly cleared reagents can be used with the Gene Profiling Array or custom signature arrays built from the U133 array.

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