Nanosphere Obtains CE Mark for Blood Culture Test

The BC-GP test expands Nanosphere’s infectious disease test capabilities to include the rapid detection of bacteria that can cause deadly bloodstream infections.  In a single automated test, the Verigene BC-GP test provides genus and species level detection for a broad panel of the most clinically significant gram-positive bacteria.  The BC-GP test also detects several crucial markers for antibiotic resistance, including the mecA, vanA, and vanB genes.  These genes can dangerously complicate the management of bloodstream infections by conferring resistance to the antibiotics methicillin/oxacillin and vancomycin.

“With the BC-GP test, clinicians treating patients suspected of deadly infections now have a first-of-its-kind diagnostic tool for detecting a broad array of disease-causing bacteria while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment decisions,” said Bill Athenson, Nanosphere’s Vice President of International Sales and Marketing.

The BC-GP test provides identification of bacteria and resistance genes from gram-positive blood culture bottles within two and a half hours, as compared with current microbiological methods, which can take up to 2-3 days. Rapid and accurate identification of bacteria and resistance markers is critical in guiding appropriate antibiotic treatment. 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 $21,000 per patient.

The sample-to-result BC-GP test automates the steps of bacterial DNA extraction and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the BC-GP test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing. In addition to its gram-positive blood culture test, Nanosphere is currently developing a test for gram-negative blood cultures that will provide genus, species, and resistance detection on the same automated platform. These tests complement a rapidly expanding test menu for infectious diseases that already includes the multiplexed Verigene RV+ respiratory virus test, and is expected to include CE-IVD tests for C. difficile and enteric pathogens in 2012.