A rapid, accurate molecular diagnostic tool can differentiate two important disease-causing Staphylococcus
bacteria, while simultaneously determining antibiotic resistance.
The Verigene automated BC-S test provides detection of Staphylococcus aureus
, S. epidermidis,
and the mecA gene. The mecA gene confers resistance to the antibiotic methicillin/oxacillin. Methicillin-resistant S.aureus
(MRSA) bacteremia is associated with a significantly higher mortality rate than methicillin-susceptible S. aureus
bacteremia, posing a substantial healthcare burden.
The BC-S test provides species and resistance detection from two types of Gram-positive blood culture bottles within two and a half hours, as compared with current microbiological culture methods, which can take up to 3 days.
Studies have shown that delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour that therapy is delayed. Rapid molecular testing of blood cultures has been shown to reduce this time, and is associated with hospital cost savings of up to USD 21,000 per patient.
A product of Nanosphere (Alachua, FL, USA), the BC-S test obtained CE-IVD marking for regulatory approval of the full BC-GP test as an in vitro diagnostic in Europe. It has now also received 510(k) clearance from the US Food and Drug Administration (FDA; Silver Spring, MD, USA) as the first phase of a stepwise process to obtain clearance for a larger test panel, which will be marketed as the Verigene BC-GP test.
The BC-S test expands Nanosphere's infectious disease test capabilities to include the rapid detection of bacteria that cause deadly bloodstream infections.
US Food and Drug Administration