Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) 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.
Adenovirus outbreaks can occur throughout the year, but are more common from late winter to early summer.[1] 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 (CDC), adenovirus is spread through: 1) close personal contact, such as shaking hands or touching, 2) the air by coughing or sneezing, and 3) touching contaminated objects or surfaces.[2] Some people infected with adenovirus can have ongoing infections without any symptoms, shedding the virus for months or even years.
Quidel's Lyra Adenovirus 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 refrigerated, non-frozen storage of key reagents, as well as other benefits.
The new Lyra Adenovirus Assay augments the growing menu of other FDA-cleared assays on the Lyra platform. The quickly expanding menu of Lyra-based infectious disease products provides healthcare 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 Corporation. "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."
Quidel now offers FDA-cleared Lyra assays for a dozen different infectious agents, including eight molecular tests for respiratory disease (Strep A, Strep C+G, Influenza A, Influenza B, human metapneumovirus (hMPV), respiratory syncytial virus (RSV), and adenovirus (HAdV)) 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).
[1] http://www.cdc.gov/adenovirus/outbreaks.html
[2] http://www.cdc.gov/adenovirus/about/transmission.html
Adenovirus outbreaks can occur throughout the year, but are more common from late winter to early summer.[1] 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 (CDC), adenovirus is spread through: 1) close personal contact, such as shaking hands or touching, 2) the air by coughing or sneezing, and 3) touching contaminated objects or surfaces.[2] Some people infected with adenovirus can have ongoing infections without any symptoms, shedding the virus for months or even years.
Quidel's Lyra Adenovirus 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 refrigerated, non-frozen storage of key reagents, as well as other benefits.
The new Lyra Adenovirus Assay augments the growing menu of other FDA-cleared assays on the Lyra platform. The quickly expanding menu of Lyra-based infectious disease products provides healthcare 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 Corporation. "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."
Quidel now offers FDA-cleared Lyra assays for a dozen different infectious agents, including eight molecular tests for respiratory disease (Strep A, Strep C+G, Influenza A, Influenza B, human metapneumovirus (hMPV), respiratory syncytial virus (RSV), and adenovirus (HAdV)) 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).
[1] http://www.cdc.gov/adenovirus/outbreaks.html
[2] http://www.cdc.gov/adenovirus/about/transmission.html