Quidel secures FDA 510(k) clearance for lyra adenovirus assay

13 October 2014 (Last Updated October 13th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel to market its lyra adenovirus assay, a real-time PCR test for the qualitative detection of human adenovirus (HAdV) viral DNA, isolated from nasal swab and nasopharyngeal swab specimens.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel to market its lyra adenovirus assay, a real-time PCR test for the qualitative detection of human adenovirus (HAdV) viral DNA, isolated from nasal swab and nasopharyngeal swab specimens.

Adenoviruses are medium-sized, non-enveloped viruses with an icosahedral nucleocapsid containing a double stranded DNA genome.

These viruses can cause several illnesses and symptoms including colds, bronchitis, pneumonia, diarrhea, pink eye, fever and a sore throat.

Adenovirus is spread through close personal contact, the air and touching contaminated objects or surfaces, according to the Centers for Disease Control and Prevention (CDC).

"The new lyra adenovirus assay is part of the exciting new lyra brand of ready-to-use, molecular PCR reagent kits specially designed to be compatible with a laboratory's existing thermocycler."

The new lyra adenovirus assay is part of the new lyra brand of ready-to-use, molecular PCR reagent kits specially designed to be compatible with a laboratory's existing thermocycler.

The lyra reagent kits offer features including a short time for results, ready-to-use master mix and refrigerated, non-frozen storage of key reagents, as well as other benefits.

Quidel said that new lyra adenovirus assay augments the growing menu of other FDA-cleared assays on the lyra platform.

The lyra-based infectious disease products provides healthcare workers with the flexibility needed to meet the specific needs of the clinical laboratory, as testing needs shift for specific pathogens with overlapping and variable seasonality.

Quidel president Douglas Bryant said: "We are pleased to receive 510(k) clearance for our lyra adenovirus assay.

"This assay adds depth to our molecular respiratory solutions, and when paired with our other lyra assays, provides customers with the power to customise their testing strategies in response to their unique local or seasonal prevalence demands."

Quidel is a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems.

The company provides FDA-cleared lyra assays for a dozen different infectious agents, including eight molecular tests for respiratory disease and four other PCR assays for other serious infectious disease pathogens.