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FDA Clears Quidel's RSV, hMPV Molecular Assay

NEW YORK (GenomeWeb News) – Quidel has received US Food and Drug Administration 510(k) clearance to market its molecular respiratory viral panel in the US, the company said on Tuesday.

The assay, called the Quidel Molecular RSV + hMPV assay, detects respiratory syncytial virus and human metapneumovirus and distinguishes the two from each other. While they are different viruses, they cause respiratory infections with very similar symptoms, Quidel said.

"Often, these infections can mimic flu-like illness and can cause ambiguity in assigning a course of treatment. For these reasons, a duplex test such as the RSV + hMPV assay can prove to be very valuable," Quidel CSO Timothy Stenzel said in a statement.

The San Diego-based firm launched the assay in Europe after receiving the CE Mark in March 2012.

The assay is the third molecular test from Quidel to receive FDA clearance in the past year, following the Quidel Molecular Influenza A+B assay for use on the Cepheid SmartCycler PCR system a year ago, and an assay for detecting Clostridium difficile, which is run on Quidel's handheld AmpliVue instrument, in December.

The company received its first FDA clearances for its molecular assays — for Influenza A+B and hMPV — in December 2011, and last month during his company's fourth-quarter earnings conference call, Quidel CEO Douglas Bryant said that the firm anticipates launching seven PCR-based assays in 2013.

"We intend to broaden our menu of molecular assays over the next several quarters, and in doing so, will provide our customers with a number of easy to use infectious disease tests that can be run on their existing thermocyclers," he said in a statement on Tuesday.

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