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Quidel Gets FDA OK for Adenovirus MDx

NEW YORK (GenomeWeb) — Quidel said on Monday that it has received 510(k) clearance from the US Food and Drug Administration to market its Lyra Adenovirus Assay, a real-time PCR test for the qualitative detection of human adenovirus viral DNA from nasal and nasopharyngeal swabs.

The new test is part of Quidel's Lyra brand of ready-to-use PCR reagent kits designed for use on a laboratory's existing thermal cycler. Features of the kits include a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage.

The San Diego-based clinical diagnostics firm now offers FDA-cleared Lyra assays for a dozen different infectious agents including eight such tests for respiratory disease (Streptococcus B, Strep C+G, influenza A, influenza B, human metapneumovirus, respiratory syncytial virus, and adenovirus); as well as assays for herpes simplex viruses 1 and 2, varicella zoster virus, and Clostridium difficile.