Molecular diagnostics firm Great Basin Scientific has received approval from the US Food and Drug Administration (FDA) for its Group B Streptococcus (GBS) molecular diagnostic test.
The company intends to make the test commercially available for customers in the second quarter of this year.
Great Basin Scientific co-founder and CEO 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.
"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."
The Great Basin GBS assay is said to offer accurate results in around 90 minutes with a specimen from enriched LIM broth.
The test will provide definitive identification by targeting a highly conserved region of the cfb (CAMP factor) gene. It will also offer rapid diagnosis of the mother’s GBS colonization status compared against standard culture-based testing that will take up to an additional 48 hours.
In May 2012, the company received FDA approval for its first test for Clostridium difficile (C. Diff).
Great Basin also provides integrated cartridge system, which helps in accurate and information-rich detection of infectious diseases, capable of both low-plex and multi-plex targets.