NEW YORK (GenomeWeb News) – The US Food and Drug Administration has granted 510(k) clearance to Quidel's Molecular Influenza A+B and RSV+hMPV assays for use on Life Technologies' QuantStudio Dx Real-Time PCR instrument, the companies said today.
The Quidel Molecular Influenza A+B assay detects influenza A and/or B virus, but does not differentiate influenza A subtypes. However, the assay is able to detect subtype H7N9, which has caused more than one hundred infections to date in China, with a mortality rate of approximately 30 percent.
FDA also cleared the assay for the detection of H3N2v, a variant influenza virus that has caused infection in patients exposed to infected swine at agricultural fairs in the United States.
Meantime, the Quidel Molecular RSV+hMPV assay detects the presence of respiratory syncytial virus and/or human metapneumovirus. RSV is a respiratory virus that infects the lungs and breathing passages, and although most infections are generally mild, some can be severe, especially among young children, the immunocompromised, and the elderly.
hMPV was identified in 2001 and accounts for approximately 7.1 percent of respiratory tract infections. The virus appears to be distributed worldwide, and virtually all children have been exposed to hMPV by the age of five. Like RSV, hMPV generally causes mild respiratory tract infection, but can be severe, especially among young children, the immunocompromised, and the elderly.
Life Tech said that its QuantStudio Dx is its flagship diagnostics instrument, offering the advanced capabilities in flexible sample batching needed by higher-volume hospital and reference laboratories.
The instrument features a touch screen, reagent and sample tracking, and a laboratory information management systems interface specifically designed for ease of use in diagnostic laboratories. The instrument also features an optional test development mode for research use only and custom test development.
Both Quidel and Life Tech will sell and distribute the Quidel Molecular Influenza A+B and RSV+hMPV assays and QuantStudio Dx in the US and Europe. Both the assays and instrument are CE-IVD marked for diagnostic use in Europe.
The companies have an agreement in place to develop and commercialize real-time PCR assays for the QuantStudio Dx. Also, under a previously signed agreement, Life Tech is marketing Quidel's PCR-based assays for use on the ABI 7500 Fast Dx Real-Time PCR system in Europe.
The FDA cleared Quidel's Molecular Direct C. difficile assay for both instrument platforms in March. Meantime, Quidel's Molecular Influenza A+B and RSV+hMPV assays were previously 510(k)-cleared by the FDA for use with the ABI 7500 Fast Dx and Cepheid's SmartCycler II in 2011.