FDA Clearance Given to Quidel’s Molecular Diagnostic Test for Respiratory Syncytial Virus and Human Metapneumovirus
14 Mar 2013

Quidel Corporation, a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (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.

"We are pleased to have received FDA clearance for another molecular diagnostic product," saidDouglas Bryant, president and chief executive officer 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."

The RSV + hMPV assay is Quidel's third molecular PCR assay to receive 510(k) clearance. Quidelpreviously received FDA clearance for Quidel Molecular assays for Influenza A+B and hMPV. Quidelalso received FDA clearance for its C. difficile assay in the AmpliVue® format in December of 2012.

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