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Quidel Receives Its First FDA Clearance for MDx Assays

NEW YORK (GenomeWeb News) – Quidel announced on Friday that the US Food and Drug Administration has cleared for marketing two of its molecular tests, one for human metapneumovirus and the other for influenza A and B, making them the San Diego company's first FDA-cleared MDx tests.

The Quidel Molecular hMPV Assay is the first molecular test from the company to receive FDA 510(k) clearance, it said, adding it was launched in Europe after getting CE marked in September 2011.

FDA also cleared the Quidel Molecular Influenza A+B Assay, which was launched in Europe after receiving the CE Mark in August 2011.

Quidel said that the two assays are part of several in its expanding molecular diagnostics pipeline.

The firm has played primarily in the immunoassay market but worked with BioHelix in 2009 on a handheld platform using isothermal helicase-dependent amplification technology. Earlier this year, its CEO Doug Bryant outlined a "three-pronged approach" to an addressable MDx market that he estimated at about $760 million, as GenomeWeb Daily News' sister publication PCR Insider reported.

Quidel's PCR-based products are designed to be run on the Applied Biosystems 7500 Fast Dx thermocycler. Life Technologies, the parent firm of ABI, inked a deal in September to distribute Quidel's MDx assays.

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