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BD Diagnostics Receives FDA Clearance for GBS Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – BD Diagnostics said today that it has received 510(k) clearance from the US Food and Drug Administration to market its BD Max GBS Assay for Group B Streptococcus on the BD Max System.

GBS is a leading cause of morbidity and mortality among newborns with maternal colonization, a major risk for early onset of GBS disease, according to BD Diagnostics, a segment of Becton Dickinson. The disease, however, is treatable with antibiotics during labor, and the US Centers for Disease Control and Prevention recommends universal prenatal screening for GBS colonization and intrapartum chemoprophylaxis for colonized mothers to prevent transmission to infants.

The current standard of care for prevention of prenatal GBS disease is by screening pregnant women at 35 to 37 weeks by using cultures. Such methods, however, have limited sensitivity, long turnaround time, and depend on highly trained staff to interpret the results, BD said in a statement.

The new assay on the BD Max system can identify GBS in about one hour in Lim broth, and because it automates sample lysis through polymerase chain reaction detection, the system can analyze up to 24 samples in about two and a half hours, the company said.

The BD Max GBS assay is the only fully automated PCR method for detecting GBS from vaginal or rectal swabs after Lim broth selective enrichment, said Steve Young, scientific director for microbiology and virology at TriCore Reference Laboratories, a clinical trial sites.

"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," he said.