Quidel Gets Two FDA Clearances For Molecular Diagnostic Tests - Quick Facts

(RTTNews) - Quidel Corp. (QDEL) and Life Technologies Corp. (LIFE) announced that the United States Food and Drug Administration or FDA has granted 510(k) clearances to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay, both for use on the QuantStudio Dx Real-Time PCR Instrument by Life Technologies. The QuantStudio Dx is Life Technologies' flagship instrument for the diagnostics market, offering the advanced capabilities in flexible sample batching needed by higher-volume hospital and reference laboratories.

The Quidel Molecular Influenza A+B assay reports the presence or absence of influenza A and/or B virus; it does not differentiate influenza A subtypes. Most importantly, this molecular assay does demonstrate the analytical detection of subtype H7N9. The H7N9 subtype has caused over 100 infections to date in China, with a mortality rate of about 30 percent. The assay was also cleared to include the analytical detection of H3N2v, a variant influenza virus that has caused infection in patients exposed to infected swine at agricultural fairs in the United States.

The Quidel Molecular Influenza A+B and RSV + hMPV assays and QuantStudio Dx would be sold and distributed by both Quidel and Life Technologies in the United States, as well as in Europe. Both the assays and instrument are CE-IVD marked for diagnostic use in Europ