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

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.

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