BD MAX GBS Assay Receives FDA Clearance

BD (Becton, Dickinson and Company) has announced U.S. Food and Drug Administration (FDA) clearance of the BD MAX™ Group B Streptococcus (GBS) Assay and Clinical Laboratory Improvement Amendments (CLIA) moderate complexity test categorization on the second-generation BD MAX™ System.

GBS is the leading cause of morbidity and mortality among infants in the United Sates. The Centers for Disease Control and Prevention estimates that in recent years GBS has caused approximately 1,200 cases of early-onset invasive disease per year; approximately 70 percent of cases are among babies born at term (37 weeks gestation or more). Screening for colonization late in gestation can identify women who are likely to be colonized with GBS at the time of delivery.

The BD MAX GBS Assay is the only automated in vitro diagnostic (IVD) test for polymerase chain reaction (PCR) detection of GBS DNA in Lim Broth cultures. The assay provides an easy-to-use, cost-effective method for laboratories seeking access to a molecular method and optimized resource utilization for GBS testing. The assay will enable laboratories to comply with the 2010 CDC guidelines for GBS screening.

“FDA clearance of the BD MAX GBS Assay on the second-generation BD MAX System moves BD closer to our goal of providing a next-generation molecular testing system designed to offer and accommodate a broad range of assays,” said Gregory Meehan, Vice President, BD Diagnostics – Diagnostic Systems, Molecular Diagnostics. “By simplifying the testing for GBS colonization status, the BD MAX GBS Assay can support improved prevention and control of GBS infections in newborns.”