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Quidel Gets De Novo FDA Clearance for Combined HSV, VZV Assay

NEW YORK (GenomeWeb) — Quidel said today after the close of the market that it has received de novo clearance from the US Food and Drug Administration to market its Lyra Direct HSV 1+2/VZV multiplex real-time assay.

Quidel's assay detects and differentiates herpes simplex viruses 1 and 2 and varicella-zoster virus nucleic acids isolated and purified from swab specimens taken from cutaneous or mucocutaneous lesions on symptomatic patients.

HSV 1 is the virus responsible for most cold sores and some genital herpes transmissions, while HSV 2 is primarily responsible for most genital herpes and some cold sores. Meantime, VZV is responsible for chicken pox in children and shingles in adults.

The test is part of Quidel's portfolio of Lyra brand ready-to-use PCR reagent kits designed to be compatible with a laboratory's existing thermal cycler. According to Quidel, these kits feature a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents.

"Our Lyra assay allows us to offer a molecular diagnostic alternative to our widely used cell-based ELVIS assay for the detection and identification of herpes simplex viruses," Quidel CEO Douglas Bryant said in a statement. "The inclusion of varicella-zoster virus to the multiplex assay provides the clinician with a rapid and sensitive tool not previously available to aid in the differential diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus in humans."