NEW YORK (GenomeWeb) – Molecular diagnostics firm Great Basin Scientific announced today that the US Food and Drug Administration has granted 510(k) clearance for its Group B Streptococcus test.
The company plans a commercial launch of the GBS assay in the second quarter of 2015.
"Receiving FDA clearance for our GBS test represents a significant milestone for Great Basin, both as an expansion of our menu and as evidence of the company's ability to meet product deliverables," Great Basin CEO and Co-founder and CEO Ryan Ashton said in a statement.
"We look forward to growing our menu of tests over the next 18 months to further meet the need for easy-to-use and cost-effective molecular diagnostic testing," he said.
Between 10 and 30 percent of women are thought to carry GBS. Colonization of the urogenital tract often causes no symptoms, but infection can lead to morbidity and mortality in newborns. About 1,000 babies per year contract an early-onset form of infection, with similar rates of late-onset disease, according the US Centers for Disease Control and Prevention.
Screening for GBS is therefore recommended by the CDC for all expectant mothers between 35 to 37 weeks of gestation, and Great Basin also noted in a statement that there are about 4 million live births in the US each year.
The GBS integrated cartridge test takes 90 minutes, using a specimen that is first cultured in LIM broth to enrich for the bacteria.
The test is the second of the company's assays to be FDA cleared; the first was a Clostridium difficile test in 2012.
That test was subsequently shown to be as sensitive and specific as established C. diff PCR assays from Cepheid and Becton Dickinson, firms that also have FDA-cleared GBS tests. Great Basin reported a 51 percent rise in fourth quarter revenues last year attributed to sales of its C. diff test.