HOUSTON, July 13 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.
SeqWright Incorporated is a world-class genomic services support organization based in Houston, Texas with more than a decade of experience specializing in providing access to state-of- the-art molecular biology and genomic services in a highly regulated GLP/CLIA environment. For additional information about SeqWright and its services, please visit www.seqwright.com.
About EraGen Biosciences
EraGen Biosciences develops, manufactures and markets innovative molecular diagnostic products that are driving a new era in clinical diagnostics and research. The company's in-market and pipeline products, based on its novel, patented MultiCodeŪ platform chemistry, are the next generation of DNA- and RNA-based testing for the early detection of infectious diseases and genetic conditions. EraGen's expanding menu of high-quality, easy-to-use products position the company for leadership in molecular diagnostics. For more information, visit the EraGen website at www.eragen.com.
SOURCE SeqWright, Inc.