Great Basin Scientific, a molecular diagnostics company, announced it has submitted its Group B Strep assay to the US Food and Drug Administration (FDA) for 510(k) clearance.
The submission of the Group B Strep assay comes after the successful completion of a clinical trial that met all the Company’s objectives. The trial included 518 prospective samples at several hospital-based clinical laboratories in the United States. Great Basin anticipates commercial release of the Group B Strep assay in the second quarter of 2015, pending FDA clearance.
Group B Streptococcus, or GBS, continues to be a major perinatal pathogen, for both mothers and their infants, and is the leading cause of early-onset sepsis and meningitis in the United States.
The Great Basin GBS sample-to-result assay is used to detect Streptococcus agalactiae (group B Streptococcus) from vaginal/rectal swabs collected from antepartum women at weeks 35-37 of pregnancy in an enriched LIM broth.
The results aid physicians in determining if antibiotic treatment needs to be given to the pregnant woman to prevent the transmission of GBS to the child during delivery.
"With the Company’s recent IPO, we now have the resources to move a significant number of projects from R&D into a final development and clinical trial phase," said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin. "