Nanosphere Receives FDA Clearance for Automated Detection of Staphylococcus

The molecular diagnostics company Nanosphere has announced that it has been granted FDA (US Food and Drug Administration) approval for its Verigene staphylococcus blood culture nucleic acid test (BC-S). The BC-S test allows for the rapid detection of bacteria capable of causing Septicemia.

Septicemia occurs when a pathogenic microorganism enters the bloodstream causing an inflammatory immune response. These bloodstream infections are associated with high mortality rates and are responsible for more than 800,000 hospitalizations a year in the US.

Gram positive bacterial infections are often complicated by antimicrobial resistance. The inability to rapidly identify resistant strains of pathogenic bacteria has led to antimicrobial use that is often ineffectual, wasteful, or runs the risk of proliferating resistant strains. Gram-positive bacteria are also a common source of sample contamination during blood collection. Rapid identification of both organism and resistance is essential to implementing efficient and appropriate therapy, and in reducing the number of patients falsely started on antimicrobial medication.

The BC-S test offers species and resistance detection from two types of gram-positive blood culture bottles within two and a half hours, compared to a turnaround time of up to three days using conventional methods. The rapid testing time is enabled by automation of bacterial nucleic acid extraction and target detection on the Verigene System. The BC-S 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.

“With the BC-S test, clinicians diagnosing patients suspected of deadly infections have a rapid, accurate 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.,” said Nanosphere CEO Bill Moffitt. “With this clearance we continue expansion of our product offering, enabling microbiologists to replace century-old methods with rapid, accurate molecular diagnostic tests,” he added.