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Quidel obtains FDA 510(k) approval for AmpliVue HSV 1+2 assay

Quidel has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its AmpliVue HSV 1+2 assay, designed to differentiate and detect herpes simplex viruses 1 and 2.

The AmpliVue HSV 1+2 assay, which requires no upfront extraction of DNA, provides accurate results in approximately one hour. The assay also does not require investment in expensive thermocycling equipment and thus it can lower a laboratory’s cost to adopt and maintain molecular testing methods.

According to Quidel, its AmpliVue product line now enables laboratories of all sizes to perform highly sensitive and specific molecular tests for two viruses and two bacterial species without incurring the significant expense that is usually required to adopt and maintain molecular testing methods on-site.

AmpliVue HSV 1+2 is the company’s third assay to launch in its hand-held, disposable format. The company obtained FDA approval in December 2013 for its AmpliVue C. difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA.

In December 2013, the company also obtained FDA approval for its AmpliVue GBS assay for the molecular detection of Group B Streptococcus infections.

Quidel president and CEO Douglas Bryant noted the company is pleased to launch its third AmpliVue assay and are certainly delighted by the acceleration in the pace of AmpliVue product development by its organization since BioHelix’s acquisition in May 2013.

"Hospitals are becoming increasingly aware of the AmpliVue brand, and we plan to build on that momentum with even more AmpliVue product introductions later this year," Bryant added.

The company’s three assays are now available for sale throughout the US and Europe, with several other assays currently in development.