Quidel Corp., a San Diego-based diagnostics company, announced that it has received 510 (k) clearance from the U.S. Food and Drug Administration to market its Lyra Adenovirus Assay, a real-time PCR test for the qualitative detection of human adenovirus (HAdV) viral DNA.
The test is part of the new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler.
The new Lyra Adenovirus Assay augments the growing portfolio of other FDA-cleared assays on the Lyra platform by Quidel (NASDAQ: QDEL). The quickly expanding menu of Lyra-based infectious disease products provides health care workers with the flexibility needed to meet the specific needs of the clinical laboratory, especially as testing needs shift for specific pathogens with overlapping and variable seasonality. The Lyra assays yield highly sensitive, quantitative PCR results within 75 minutes.
"We are pleased to receive 510(k) clearance for our Lyra Adenovirus Assay," said Douglas Bryant, president and chief executive officer of Quidel. "This assay adds depth to our molecular respiratory solutions, and when paired with our other Lyra assays, provides customers with the power to customize their testing strategies in response to their unique local or seasonal prevalence demands."
Adenovirus outbreaks can occur throughout the year, but are more common from late winter to early summer. Adenovirus infections are seldom life-threatening, however, these viruses can cause several illnesses and symptoms, such as colds, sore throat, bronchitis, pneumonia, diarrhea, pink eye and fever. Severe complications from adenovirus infection can present in infants and people with weakened immune systems.
According to the Centers for Disease Control and Prevention, adenovirus is spread through close personal contact, such as shaking hands or touching, the air by coughing or sneezing, and touching contaminated objects or surfaces. Some people infected with adenovirus can have ongoing infections without any symptoms, shedding the virus for months or even years.