FDA Clearance for Quidel RSV and hMPV Molecular Tests
Quidel Corporation has received 510(k) clearance from the FDA for its Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (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 United States. The product launched in Europe shortly after receiving the CE Mark in March of 2012.
'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.'
This is one of several forthcoming assays from Quidel's expanding molecular diagnostics programs. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing molecular testing infrastructure, such as Life Technologies' Applied Biosystems® 7500 Fast DX thermocycler. These reagents provide attractive features that include simple transport and refrigerated storage (no freezer required), convenient workflow, a short time to result, and other benefits that favorably affect diagnostic test outcome. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside other Quidel Molecular assays, such as Influenza A+B PCR assay, in the same multi-well panel for customized multiplexing capability.
Tags: Influenza, PCR, Respiratory Syncytial Virus, FDA
Date Published: March 26, 2013
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