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FDA Clears Quidel's Solana Herpes, Varicella Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration has cleared an assay on Quidel's Solana platform to detect and differentiate herpes simplex viruses types 1 and 2 and varicella-zoster virus.

The test does not require upfront DNA extraction, detecting HSV-1, HSV-2, and VZV DNA in cutaneous or mucocutaneous lesion samples from symptomatic patients, including specimens collected in transport media. The Solana platform employs the firm's helicase-dependent amplification technology, and processes up to 12 samples per run, with run time of about one-hour.

"The Solana HSV-1+2/VZV assay broadens our molecular diagnostic offerings for women's health assays in the moderately complex setting," Quidel President and CEO Douglas Bryant noted in a statement. The firm reported a five percent rise in revenues last quarter on sales of women's health products.

There are 800,000 new genital HSV-2 infections per year in the US, Quidel noted, with 1 in 6 people between the ages of 14 to 49 carrying the infection, about 87 percent of whom have never received a clinical diagnosis. HSV-1 is more commonly associated with non-genital locations, although both serotypes can infect any bodily site. Also in the Herpesviridae family, varicella-zoster virus commonly causes chicken pox in children. Like HSV, it remains dormant in nerve cells after infection and can reactivate in about 10 to 20 percent of cases later in life to cause shingles.

The new test adds to a Solana menu that now includes four other FDA-cleared assays: Strep Complete, Group A Strep, Influenza A+B, and Trichomonas.