Dec. 19, 2019—DiaSorin Molecular has received FDA clearance for its Simplexa VZV Swab Direct assay. The CLIA moderate-complexity assay is designed for use on the Liaison MDX instrument to detect varicella-zoster virus DNA from cutaneous and mucocutaneous swab specimens. This assay complements the company’s Simplexa VZV Direct kit, which is for use with cerebrospinal fluid samples.
“With this release, we now offer a comprehensive menu of VZV and HSV tests from cerebrospinal fluid, mucocutaneous swab specimens, and cutaneous swab specimens,” Michelle Tabb, chief scientific officer of DiaSorin Molecular, said in a company statement. Customers can also run the tests at the same time using the same disc, Tabb said.
The assay received the CE mark in September.