EraGen Biosciences Inc., Madison, Wis., was congratulated today by SeqWright, Inc., Houston, on EraGen's successful FDA 510(k) market clearance of its MultiCode-RTx HSV 1 & 2 Kit. This new kit is the first FDA-cleared PCR-based qualitative in vitro diagnostic test for the detection and typing of HSV-1 and HSV-2 from vaginal lesion swab specimens in symptomatic female patients. The kit will be used as an aid in the diagnosis of genital herpes infection. With SeqWright's significant contributions, EraGen said it was able to obtain the FDA clearance in record time.
SeqWright is a GLP-compliant, CLIA-certified leader in the field of contract genomics and is proud to have provided the FDA-level Sanger Sequencing, HSV type calling and genotyping analysis, which validated EraGen's MultiCode-RTx HSV 1&2 Kit.