DiaSorin Molecular Receives FDA Clearance for Simplexa™ VZV Swab Direct Molecular Assay
Cypress, Calif. (December 17, 2019) – DiaSorin Molecular LLC announced today that it 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 quickly and accurately detect varicella-zoster virus (VZV) DNA from cutaneous and mucocutaneous swab specimens. The company also attained CE Marketing for the assay in September. This assay complements the company’s Simplexa VZV Direct kit, which is for use with CSF samples.