FDA grants 510(k) clearance for Great Basin’s GBS molecular diagnostic test

22 April 2015 (Last Updated April 22nd, 2015 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for US-based molecular diagnostics firm Great Basin Scientific's Group B Streptococcus (GBS) molecular diagnostic test.

Streptococci

The US Food and Drug Administration (FDA) has granted 510(k) clearance for US-based molecular diagnostics firm Great Basin Scientific's Group B Streptococcus (GBS) molecular diagnostic test.

This is the company's second assay to be cleared by the FDA, while its first test for Clostridium difficile (C Diff) was approved in May 2012.

According to the company, the GBS assay will be commercially available for customers in the second quarter of 2015.

Great Basin Scientific co-founder Ryan Ashton said: "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.

"The GBS assay is designed to offer accurate results in 90 minutes with a specimen from enriched LIM broth."

"We are committed to delivering to hospitals and reference labs the products they need to quickly report accurate, definitive results, thus we are pleased with the on-time delivery of this test clearance.

"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."

The GBS assay is designed to offer accurate results in 90 minutes with a specimen from enriched LIM broth. The molecular assay will provide definitive identification by targeting a highly conserved region of the cfb (CAMP factor) gene.

The test will also offer rapid diagnosis of the mother's GBS colonisation status compared against standard culture-based testing that will take up to an additional 48 hours.

Test results provide the physician with important information for making appropriate, timely therapeutic decisions to prevent the spread of this disease to the infant during delivery.

The company's integrated cartridge system allows for more accurate and information-rich detection of infectious diseases, capable of both low-plex and multiplex targets.


Image: Gram-stained smear of streptococci. Photo: courtesy of User:Graham Beards.