DiaSorin Molecular LLC’s Simplexa® HSV 1 & 2 Direct Assay Receives FDA Clearance for Extended Swab Sample Claims
DiaSorin Molecular LLC announced today that the company has 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. FDA clearance of the assay for testing cerebrospinal fluid (CSF) samples was received in 2014. With these additional sample types, the DiaSorin Molecular Simplexa HSV 1 & 2 assay now has the most comprehensive sample type coverage for HSV testing in the market. CE Marking for these extended sample claims was attained late last year.