The US Food and Drug Administration (FDA) has granted de novo petition to market Nanosphere's gram-positive blood culture nucleic acid test (BC-GP) on the automated sample-to-result Verigene system.
Single automated BC-GP test detects genus and species level of gram-positive bacteria as well as identifies markers for antimicrobial resistance mecA, vanA, and vanB genes, which confer resistance to methicillin/oxacillin and vancomycin antibiotics.
The BC-GP test identifies gram-positive bacteria and antimicrobial resistance genes from blood culture bottles within two and a half hours, when compared to current microbiological methods which takes up to two to three days.
Nanosphere chief executive officer William Moffitt said, "With the BC-GP test, patients suspected of deadly infections can now get a first-ever diagnostic tool for detecting disease-causing bacteria while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment."
In addition to BC-GP test, Nanosphere is developing a test for gram-negative blood cultures that will provide genus, species, and resistance detection on the same automated sample-to-result Verigene platform.
