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Affymetrix Files for FDA Clearance of CytoScan HD

NEW YORK (GenomeWeb News) – Affymetrix has filed its CytoScan cytogenetics platform with the US Food and Drug Administration, a company official said at the Leerink Swann Global Healthcare Conference yesterday.

"We have ... completed the CytoScan filing with the FDA," Affy CFO Tim Barabe said at the conference. "So it's in the works, it's with them.

"Clearly we expect to expand in translational medicine, clinical diagnostics, and applied markets, so there are some exciting products that we expect to launch in 2013, as well as we expect to continue to make progress with our cytogenetics product," he added.

The firm said during its fourth-quarter earnings conference call two weeks ago that its cytogenetics portfolio now accounts for about 10 percent of its total revenues. The CytoScan products brought in $30 million in revenues last year, compared to $10 million in 2011.

Affymetrix CEO Frank Witney has said that cytogenetics represents an annual opportunity of $800 million, with about $500 million of that opportunity in cancer cytogenetics and about $200 million in postnatal constitutional cytogenetics, of which half is still done using classical karyotyping.

An Affy official told GenomeWeb Daily News today that the firm can't say when it anticipates receiving FDA clearance for CytoScan, but Affy has previously said that it expects having an FDA-cleared cytogenetics product on the market by the middle of the year.

As reported recently by GenomeWeb Daily News sister publication BioArray News, Affy's competitors in the market, Illumina and Agilent, both have plans to file their array-based cytogenetic products with FDA. Illumina has said that it intends to file with the FDA this quarter, while Agilent is targeting a submission next year.

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