Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received clearance, via the De Novo Request process, from the United States Food and Drug Administration (FDA) to market its Lyra(TM) Direct HSV 1+2/VZV multiplex real-time PCR assay. This new molecular test detects and differentiates herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) nucleic acids isolated and purified from swab specimens taken from cutaneous (skin) or mucocutaneous (e.g., mouth, lips, or genitals) lesions on symptomatic patients.
Quidel's latest assay for HSV 1+2/VZV is part of its exciting new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler.(1) The Lyra reagent kits provide attractive features that include a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents, as well as other benefits.
Lyra Direct HSV1+2/VZV Assay distinguishes between three pathogenic viruses: HSV 1, the virus responsible for most cold sores and some genital herpes transmissions; HSV 2, the virus primarily responsible for most genital herpes and some cold sores; and VZV, the virus responsible for chicken-pox in children and shingles among adults. The Centers for Disease Control and Prevention (CDC) estimates 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.(2)
The Lyra Direct HSV 1+2/VZV Assay kit includes an extraction-free, three-step sample preparation process that does not require time-consuming automated extraction. This fast and easy direct-to-amplification procedure allows the assay to generate a result in approximately 50 minutes.
"We are pleased to receive FDA clearance for our Lyra Direct HSV 1+2/VZV Assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our Lyra assay allows us to offer a molecular diagnostic alternative to our widely used cell-based ELVIS assay for the detection and identification of herpes simplex viruses. The inclusion of varicella-zoster virus to the multiplex assay provides the clinician with a rapid and sensitive tool not previously available to aid in the differential diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus in humans."
Quidel also offers FDA-cleared, molecular diagnostic assays under the Lyra brand for the accurate detection of other infectious diseases, such as those caused by Influenza A+B, Respiratory Syncytial Virus, Human Metapneumovirus, Clostridium difficile, and Group A and pyogenic Group C or G Streptococcus.
Quidel's AmpliVue product line offers FDA-cleared, hand-held molecular diagnostic assays for the accurate detection of Clostridium difficile, Group B Streptococcus, and herpes simplex viruses 1 and 2.
The four Lyra and three AmpliVue assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.
Quidel's latest assay for HSV 1+2/VZV is part of its exciting new Lyra brand of ready-to-use, molecular PCR reagent kits specifically designed to be compatible with a laboratory's existing thermocycler.(1) The Lyra reagent kits provide attractive features that include a short time to result, ready-to-use master mix, and refrigerated, non-frozen storage of key reagents, as well as other benefits.
Lyra Direct HSV1+2/VZV Assay distinguishes between three pathogenic viruses: HSV 1, the virus responsible for most cold sores and some genital herpes transmissions; HSV 2, the virus primarily responsible for most genital herpes and some cold sores; and VZV, the virus responsible for chicken-pox in children and shingles among adults. The Centers for Disease Control and Prevention (CDC) estimates 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.(2)
The Lyra Direct HSV 1+2/VZV Assay kit includes an extraction-free, three-step sample preparation process that does not require time-consuming automated extraction. This fast and easy direct-to-amplification procedure allows the assay to generate a result in approximately 50 minutes.
"We are pleased to receive FDA clearance for our Lyra Direct HSV 1+2/VZV Assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our Lyra assay allows us to offer a molecular diagnostic alternative to our widely used cell-based ELVIS assay for the detection and identification of herpes simplex viruses. The inclusion of varicella-zoster virus to the multiplex assay provides the clinician with a rapid and sensitive tool not previously available to aid in the differential diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus in humans."
Quidel also offers FDA-cleared, molecular diagnostic assays under the Lyra brand for the accurate detection of other infectious diseases, such as those caused by Influenza A+B, Respiratory Syncytial Virus, Human Metapneumovirus, Clostridium difficile, and Group A and pyogenic Group C or G Streptococcus.
Quidel's AmpliVue product line offers FDA-cleared, hand-held molecular diagnostic assays for the accurate detection of Clostridium difficile, Group B Streptococcus, and herpes simplex viruses 1 and 2.
The four Lyra and three AmpliVue assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.