FDA clears "first" molecular test for herpes
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for a herpes simplex virus (HSV) test developed by EraGen Biosciences. The company claims the MultiCode RTx HSV 1&2 kit is the first FDA-cleared molecular test for the virus. The PCR-based diagnostic distinguishes between HSV-1 and HSV-2 in vaginal lesion specimens from symptomatic females. This is important because HSV-2 has a higher recurrence rate, and it is one of the most common sexually transmitted diseases in the US. Madison, Wisconsin-based EraGen says that its test has "considerable advantages" over traditional testing methods for herpes, such as cell culturing and serology, which detects antibodies to the virus. This includes "excellent" sensitivity and specificity, and rapid time to result (around four hours).