Quidel Receives FDA Clearance for Molecular Test to Detect Herpes Viruses
San Diego-based Quidel, a maker of testing solutions, diagnostic systems and virology assays, said that it has received FDA clearance to market its Lyra Direct HSV 1 and 2/VZV multiplex real-time PCR assay.
The new molecular test detects and differentiates herpes simplex viruses 1 and 2 (HSV 1 and 2) and varicella-zoster virus (VZV). It uses nucleic acids isolated and purified from swab specimens taken from a patient’s cutaneous (skin) or mucocutaneous (e.g., mouth, lips, or genitals) lesions, the company said.
The Lyra Direct HSV 1 and 2/VZV Assay kit includes an extraction-free, three-step sample preparation process, the company said. They said that this assay can generate a result in 50 minutes.
HSV 1 is the virus responsible for most cold sores and some genital herpes transmissions. HSV 2 is the virus responsible for most genital herpes and some cold sores and VZV is the virus responsible for chicken-pox and shingles.
The Centers for Disease Control and Prevention says 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 are infected by the genital HSV 2 virus.
Quidel received approval for the assay via the FDA’s De Novo Request process. This allows for accelerated approval of a new device that presents a moderate or low risk profile, and for which no devices with the same intended use exist.
Quidel also offers FDA-approved assays that detect other diseases such as influenza and respiratory syncytial virus. — Kellen OwingsSubscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.