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Quidel Gets FDA Clearance for HPIV Test

NEW YORK (GenomeWeb) – Quidel has received US Food and Drug Administration 510(k) clearance for its human parainfluenza virus molecular diagnostic test, the firm said today.

The FDA cleared the Lyra Parainfluenza Assay, a real-time PCR test for the qualitative detection and identification of human parainfluenza virus infections for virus types 1, 2, or 3 viral RNA extracted from nasal swab and nasopharyngeal swab specimens. These RNA viruses are the second leading cause of hospitalizations for respiratory disease in children under five years of age in the US, according to Quidel.

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.

With the clearance of the HPIV test, Quidel now offers FDA-cleared assays for eight different respiratory disease viruses.

Earlier this week the firm said that the FDA had cleared for marketing its Lyra Adenovirus Assay, a real-time PCR test for the qualitative detection of human adenovirus viral DNA from nasal and nasopharyngeal swabs.