June 27, 2018—DiaSorin Molecular received FDA clearance extending the sample type claims of its Simplexa HSV 1 & 2 Direct assay. The clearance expands the type of samples that can be tested, from genital swabs to all cutaneous and mucocutaneous swab samples.
The Simplexa HSV 1 & 2 Direct kit real-time PCR assay, for use on DiaSorin’s Liaison MDX instrument, is intended for the in vitro qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid and swab samples. The test does not require a DNA extraction step and processes up to eight samples per run in about one hour.
“With this FDA clearance, we are able to meet our goal of offering the most comprehensive HSV molecular test available,” Michelle Tabb, VP of research and development for DiaSorin Molecular, said in a release. “We are continually growing our test menu and expanding what the individual tests can do. This makes our molecular platform very attractive to clinical laboratories.”