Quidel receives FDA clearance for respiratory viral detection assay
Mar 21, 2013 (Datamonitor via COMTEX) --
Quidel Corporation, a provider of diagnostic testing solutions and cell-based virology assays, has received 510(k) clearance from the FDA for its Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus, or RSV, and human metapneumovirus, or hMPV.
The assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms. The FDA's 510(k) clearance grants Quidel authorization to market its Quidel Molecular RSV + hMPV assay in the US.
"RSV and hMPV infections are relatively common diseases among children, and the symptoms can be indistinguishable from each other. Often, these infections can mimic flu-like illness, and can cause ambiguity in assigning a course of treatment," said Dr Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. "For these reasons, a duplex test such as the RSV + hMPV assay can prove to be very valuable."
"We are pleased to have received FDA clearance for another molecular diagnostic product," said Douglas Bryant, president and CEO of Quidel Corporation. "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."
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