NEW YORK (GenomeWeb) – Molecular diagnostics firm Great Basin Scientific today announced it has submitted a 510(k) application to the US Food and Drug Administration for marketing clearance of its Group B Strep assay for perinatal infections.
The sample-to-result assay is used to detect Streptococcus agalactiae from vaginal and rectal swabs collected from antepartum women around weeks 35 to 37 of pregnancy. The results help physicians determine if the woman needs antibiotic treatment to help prevent transmission of an infection during child birth.
"We believe our technology is unique in that [it] allows us to deliver both low-plex assays and multiplex panels, a capability that we believe no other molecular diagnostics provider is currently able to offer but that is critical for meeting the needs of the microbiology lab," Ryan Ashton, CEO and co-founder of Great Basin, said in a statement.
The Salt Lake City-based firm said it had successfully completed a clinical trial of 518 prospective samples at several hospital-based clinical laboratories in the US and it anticipates a commercial release of the Group B Strep assay in the second quarter of 2015, pending FDA clearance.
Great Basin, which recently went public in the US, produces chip-based technologies for fast, multiple-pathogen diagnoses of infectious diseases.