Quidel’s AmpliVue HSV 1+2 Assay gets FDA 510(k) clearance

31 March 2014 (Last Updated March 31st, 2014 01:00)

Quidel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its AmpliVue HSV 1+2 Assay, the third to launch in the handheld, disposable AmpliVue format.

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Quidel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its AmpliVue HSV 1+2 Assay, the third to launch in the handheld, disposable AmpliVue format.

The AmpliVue HSV 1+2 Assay is an in-vitro diagnostic test for the qualitative detection and differentiation of Herpes simplex viruses 1 and 2. It uses amplification technology with an easy-to-use, handheld device.

The assay eliminates the need of an upfront extraction of DNA and provides an accurate result in approximately one hour.

Compared with other FDA-cleared AmpliVue assays, this HSV 1+2 Assay requires no investment in expensive thermocycling equipment.

Using AmpliVue can significantly lower a laboratory's cost to adopt and maintain molecular testing methods.

Citing statistics from the US Centers for Disease Control and Prevention (CDC), Quidel said that there are almost 800,000 new cases of herpes in the US each year, and about one in six Americans aged 14 to 49 have a genital HSV 2 infection.

"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."

Quidel president and CEO Douglas Bryant said: "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."

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

In December 2013, Quidel obtained FDA clearance for AmpliVue GBS Assay for the molecular detection of Group B Streptococcus infections.

The AmpliVue C difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA received FDA clearance in December of 2012.

All three assays are now available for sale throughout the US and Europe, while diagnostic tests for other analytes of interest that will use the novel AmpliVue platform are in development.


Image: TEM micrograph of a herpes simplex virus. Photo: courtesy of CDC/Dr Erskine Palmer.