FDA clearance for herpes simplex virus molecular test, 5/15
May 2015—Seegene announced that the Food and Drug Administration has granted 510(k) market clearance for its TOCE-based herpes simplex virus types 1 and 2 assay. This is the first product Seegene has taken through the FDA, and it opens the way for the company’s other planned FDA submissions of multiplex real-time PCR reagents.