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BD Group B Streptococcus Assay Gets 'Moderate Complexity' Status

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Becton Dickinson today announced that it has received "Moderate Complexity" status from the US Food and Drug Administration for its BD Max GBS Assay for Group B Streptococcus on the BD Max System, which could hasten molecular testing for the disease.

FDA granted "Moderate Complexity" to the assay under CLIA regulations.

The BD Max GBS Assay received FDA 510(k) clearance in June.

With the new rating, the BD Max GBS Assay "will increase access to cost-effective molecular testing for a broad range of laboratories performing GBS screening," BD said in a statement. According to Phillipe Jacon, president of diagnostic systems at BD Diagnostics, a shortage of skilled lab workers continues to challenge the ability of labs to offer advanced molecular testing cost effectively. The BD GBS Max Assay was designed with such facilities in mind, he said.

The BD test will compete with Cepheid's Xpert GBS test, which also holds "Moderate Complexity" CLIA categorization from the FDA.

GBS is a leading cause of morbidity and mortality among newborns, BD noted. The current standard of care for prevention of neonatal GBS disease is to screen pregnant women at 35 to 37 weeks of gestation using culture methods, which have limited sensitivity, slow turnaround time, and a need for highly skilled technologists to interpret the results.

As the US Centers for Disease Control and Prevention and the American Congress of Obstetricians and Gynecologists and others update guidelines to prevent neonatal GBS disease, one provisional recommendation is to include PCR from Lim broth as an option for antenatal screening, according to BD.

The BD Max GBS Assay is the only fully automated PCR method with a Lim broth claim, which provides high sensitivity and rapid results for detecting GBS, BD said.

"Moderate complexity" is a rating given by the FDA under CLIA to commercially marketed in vitro diagnostic tests based on their risks to public health. The other two ratings are "Waived tests," considered to have the lowest risk, and "Tests of high complexity," considered to have the highest.

With the "Moderate Complexity" status, the BD Max GBS Assay "is an efficient and effective option for laboratories looking to convert their GBS testing to a molecular method," BD said. The assay is the first offering from a "broad menu" of infectious diseases being developed by the firm for the BD Max System, it added.

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