Nanosphere Inc Receives FDA Authorization To Market Gram-Positive Blood Culture Test

Nanosphere Inc announced the U.S. Food and Drug Administration has granted a de novo petition permitting marketing of its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the automated sample-to-result Verigene System. The BC-GP test notably expands Nanosphere's infectious disease test capabilities to include fast detection of bacteria that can cause deadly bloodstream infections, an increasingly recognized health threat. With a single automated test, the Verigene BC-GP test provides fast genus and species level detection for a broad panel of clinically gram-positive bacteria. The BC-GP test also detects several crucial markers for antimicrobial resistance, including the mecA, vanA, and vanB genes, which confer resistance to the antibiotics methicillin/oxacillin and vancomycin. Rapid detection of these antimicrobial resistance markers provides vital information for clinicians to determine the treatment for bloodstream infections.