The US Food and Drug Administration (FDA) has granted 510(k) approval to Nanosphere's Verigene staphylococcus blood culture nucleic acid test (BC-S).
The BC-S test offers species and resistance detection from two types of gram-positive blood culture bottles within two and a half hours by automating the steps of bacterial nucleic acid extraction and target detection on the Verigene System.
The test includes up to 16 bacterial/resistance marker targets which can detect Staphylococcus aureus, Staphylococcus epidermidis and the mecA gene on a single test cartridge.
Nanosphere CEO Bill Moffitt said with the BC-S test, clinicians diagnosing patients suspected of deadly infections have a molecular diagnostic tool which can differentiate two important disease-causing Staphylococcus bacteria, while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment decisions.