Roche announces FDA 510(k) clearance for cobas HSV 1 and 2 Test
Roche announced today that the US Food and Drug Administration has provided 510(k) clearance for the cobas HSV 1 and 2 Test for the direct detection and differentiation of HSV-1 and HSV-2 DNA in anogenital specimens from symptomatic patients. With dual target detection and automation, the cobas HSV 1 and 2 Test provides laboratories with the capability to report up to 94 results in significantly less time than traditional methods and provides a simplified workflow for sample handling in the laboratory.