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Quidel gets FDA 510(k) clearance for new Solana molecular assay

MDBR Staff Writer Published 30 November 2016

Diagnostic testing solutions provider Quidel has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Solana HSV-1+2/VZV assay for the detection of herpes simplex virus 1+2 and varicella zoster virus.

The assay is intended for the qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples.

The samples will be collected from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster infection.

Varicella-zoster virus, which is a DNA virus of the family Herpesviridae, will primarily result in chickenpox, as well as encephalitis or pneumonia.

Solana HSV-1+2/VZV assay can be performed with many commonly used transport media, requires no upfront extraction of DNA and generates three accurate results in less than an hour.

Featuring helicase-dependent amplification (HDA) technology, Solana can process up to 12 patient samples in each run even in moderately complex settings.

Earlier, the company secured 510(k) clearance for Solana Strep Complete assay, Solana Influenza A+B assay, Solana Trichomonas assay and Solana Group A Strep assay.

Quidel president and CEO Douglas Bryant said: “Our latest product introduction, the Solana® HSV-1+2/VZV assay, broadens our molecular diagnostic offerings for Women's Health assays in the moderately complex setting.

"We believe that the Solana platform will provide the laboratorian with a fast and accurate method to diagnose many Women's Health conditions, including shingles, herpes, and trichomonas infections."