Quidel Receives FDA Clearance for its Lyra™ Molecular PCR Assay
News Oct 21, 2014
Quidel Corporation has announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its Lyra Parainfluenza Assay, a real-time PCR test for the qualitative detection and identification of human parainfluenza virus (HPIV) infections for virus types 1, 2, or 3 viral RNA extracted from nasal swab and nasopharyngeal swab specimens.
HPIVs are negative-sense, single-stranded, enveloped RNA viruses. They are the second leading cause of hospitalizations for respiratory disease in children under five years of age in the United States.
HPIV-1 and to a lesser extent HPIV-2 are most often associated with croup and bronchitis in children, whereas HIPV-3 is more frequently associated with bronchiolitis and pneumonia. HPIVs commonly infect infants and young children, but anyone can become infected with HPIV. There is no vaccine for HPIV.
Quidel's Lyra Parainfluenza Assay is part of the exciting new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler.
The Lyra reagent kits provide attractive features, including a short time to result, ready-to-use master mix, and the absence of frozen storage of key reagents, as well as other benefits. The Lyra assays yield highly sensitive, qualitative PCR results within 75 minutes.
The Lyra Parainfluenza Assay expands Quidel's menu of high quality FDA-cleared molecular assays to eight different respiratory disease viruses - two of which, RSV and HPIVs - are the two leading causes of childhood hospitalizations for respiratory disease in the United States and account for healthcare charges exceeding $750 million per year in the United States.
"We are delighted to receive 510(k) clearance for yet another Lyra assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Over the last couple years, we've become experts at developing and introducing molecular assays that, like the Lyra Parainfluenza Assay, offer flexible and distinct workflow advantages over competitive diagnostics."
Quidel now offers FDA-cleared Lyra assays for fifteen different infectious agents, including eleven molecular tests for respiratory disease (Strep A, Strep C+G, Influenza A, Influenza B, human metapneumovirus (hMPV), respiratory syncytial virus (RSV), adenovirus (HAdV), and HPIV-1, -2, and -3) and four other PCR assays for other serious infectious disease pathogens (herpes simplex virus (HSV) types 1 and 2, varicella zoster virus (VZV) and C. difficile).
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