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) for the sale of its AmpliVue HSV 1+2 Assay for the differentiation and detection of herpes simplex viruses 1 and 2.
The AmpliVue HSV 1+2 Assay is easy-to-use, handheld and disposable. The assay requires no upfront extraction of DNA and generates an accurate result in approximately one hour. Like other previously FDA-cleared AmpliVue assays, the AmpliVue HSV 1+2 Assay does not require investment in expensive thermocycling equipment. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.
The Centers for Disease Control and Prevention (CDC) estimate that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection.(1)
"We are pleased to launch our third AmpliVue assay and are certainly delighted by the acceleration in the pace of AmpliVue product development by our organization since BioHelix's acquisition in May of last year," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Hospitals are becoming increasingly aware of the AmpliVue brand, and we plan to build on that momentum with even more AmpliVue product introductions later this year."
The AmpliVue product line now enables laboratories of all sizes to perform highly sensitive and specific molecular tests for four pathogens -- two viruses and two bacterial species -- without incurring the significant expense that is usually required to adopt and maintain molecular testing methods on-site. The AmpliVue HSV 1+2 is Quidel's third assay to launch in its hand-held, disposable format. The AmpliVue C. difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA received FDA clearance in December of 2012. The AmpliVue GBS Assay for the molecular detection of Group B Streptococcus infections received FDA clearance in December of 2013. All three assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.
(1) http://www.cdc.gov/std/Herpes/STDFact-Herpes.htm
The AmpliVue HSV 1+2 Assay is easy-to-use, handheld and disposable. The assay requires no upfront extraction of DNA and generates an accurate result in approximately one hour. Like other previously FDA-cleared AmpliVue assays, the AmpliVue HSV 1+2 Assay does not require investment in expensive thermocycling equipment. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.
The Centers for Disease Control and Prevention (CDC) estimate that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection.(1)
"We are pleased to launch our third AmpliVue assay and are certainly delighted by the acceleration in the pace of AmpliVue product development by our organization since BioHelix's acquisition in May of last year," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Hospitals are becoming increasingly aware of the AmpliVue brand, and we plan to build on that momentum with even more AmpliVue product introductions later this year."
The AmpliVue product line now enables laboratories of all sizes to perform highly sensitive and specific molecular tests for four pathogens -- two viruses and two bacterial species -- without incurring the significant expense that is usually required to adopt and maintain molecular testing methods on-site. The AmpliVue HSV 1+2 is Quidel's third assay to launch in its hand-held, disposable format. The AmpliVue C. difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA received FDA clearance in December of 2012. The AmpliVue GBS Assay for the molecular detection of Group B Streptococcus infections received FDA clearance in December of 2013. All three assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.
(1) http://www.cdc.gov/std/Herpes/STDFact-Herpes.htm