Rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems provider Quidel Corporation has received approval from the US Food and Drug Administration (FDA) to market its Lyra Direct HSV 1+2/VZV multiplex real-time PCR assay.
The assay, which was cleared through De Novo Request process, identifies and differentiates herpes simplex viruses 1 and 2 (HSV 1+2) and varicella-zoster virus (VZV) nucleic acids.
The assay differentiates between three pathogenic viruses, namely 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 HSV 1+2/VZV test involves an extraction-free, three-step sample preparation process and generates a result in approximately 50 minutes.
Quidel Corporation president and chief executive officer Douglas Bryant said Lyra assay allows the company to offer a molecular diagnostic alternative to its 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," Bryant added.
There are almost 800,000 new cases of herpes in the US each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection, according to the Centers for Disease Control and Prevention (CDC).
The Direct HSV 1+2/VZV test is part of the company’s Lyra brand of ready-to-use, molecular PCR reagent kits, which are compatible with a laboratory’s existing thermocycler.
Image:TEM micrograph of a herpes simplex virus. Photo: Courtesy of CDC/Dr. Erskine Palmer.