BD Diagnostics receives 510(k) clearance to market GBS assay on BD MAX System

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the BD MAX™ GBS Assay for Group B Streptococcus (GBS) on the BD MAX™ System. The BD MAX System is a next-generation automated workstation for molecular testing designed to streamline workflow and offer full walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility.

"The BD MAX GBS assay is the first test in a complementary menu to BD's infectious diseases portfolio," said Philippe Jacon, President, BD Diagnostics – Diagnostic Systems. "This achievement further demonstrates BD's commitment to providing the best solutions to optimize lab efficiency and productivity that enable lab personnel to perform other tasks during a test run."

GBS remains one of the leading causes of morbidity and mortality among newborns, with maternal colonization serving as a major risk factor for early onset GBS disease.  However, it is preventable with antibiotics during labor, which prevents transmission from mother to infant. The U.S. Centers for Disease Control and Prevention (CDC) recommends universal prenatal screening for GBS colonization and intrapartum chemoprophylaxis for colonized mothers in order to prevent transmission to infants. The current standard of care for preventing neonatal GBS disease is screening pregnant women at 35 to 37 weeks of gestation using culture methods, which are limited by sensitivity, turnaround time and the need for highly trained technologists to interpret the results.

"The BD MAX GBS assay on the BD MAX System is the only fully automated polymerase chain reaction method for the detection of GBS from vaginal/rectal swabs after Lim broth selective enrichment," said Dr. Steve Young, TriCore Reference Laboratories, a clinical trial site. "As new CDC guidelines emerge to include molecular testing as an alternative to culture for detecting GBS, the BD MAX GBS assay could serve as an efficient, sensitive and specific option for laboratories desiring to utilize a molecular method."

The BD MAX GBS assay on the BD MAX System represents a significant advance in neonatal healthcare by streamlining the GBS screening process and addressing the limitations of current culture methods by providing rapid, objective results. With no visual interpretation required, the BD MAX GBS assay identifies GBS in just over an hour from Lim broth, which can help ensure that colonization status is available in the case of preterm delivery. By automating sample lysis through polymerase chain reaction detection, the BD MAX System offers walkaway convenience for up to 24 samples in approximately two and a half hours.