BD (Becton, Dickinson and Company) has announced that the 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. The BD MAX GBS Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures - enabling laboratories to comply with the 2010 CDC guidelines for GBS screening.
The BD MAX GBS Assay is the only automated IVD method for polymerase chain reaction (PCR) detection of GBS from Lim Broth with a moderate complexity test categorization. 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. BD MAX is the first and only automated, bench-top molecular system designed to perform a broad range of molecular testing, offering unmatched flexibility and versatility.
"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."
GBS is the leading infectious cause of morbidity and mortality among infants in the United States. 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.
According to Meehan, clearance and categorization of the BD MAX GBS Assay as moderate complexity are important milestones. As we work to develop methicillin-resistant Staphylococcus aureus and Clostridium difficile assays in the months ahead, and additional assays in the years ahead, we believe the BD MAX System is well positioned to potentially be a vital resource for the widest possible range of laboratory testing needs.