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Dx Focus: Quidel Gets FDA OK for HSV 1 and 2 Assay

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Quidel said last week that it has received 510(k) clearance from the US Food and Drug Administration for its AmpliVue HSV 1+2 assay for the differentiation of herpes simplex viruses 1 and 2.

AmpliVue HSV 1+2 uses helicase-dependent amplification technology, an isothermal amplification method, and as such is easy to use, handheld, and disposable, and does not require expensive thermal cycling equipment, Quidel said.

The assay also requires no upfront extraction of DNA, and generates a result in approximately one hour.

AmpliVue HSV 1+2 is Quidel's third assay to launch in its hand-held, disposable format. The AmpliVue C. difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA received FDA clearance in December of 2012. The AmpliVue GBS assay for the molecular detection of Group B Streptococcus infections received FDA clearance in December of 2013. All three assays are now available for sale throughout the US and Europe, with several other assays currently in development, Quidel said.

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