FDA Designates Nanosphere's Bloodstream Infection Test Moderate Complexity
Nanosphere (NASDAQ: NSPH) announced today that it received notice from the U.S. Food and Drug Administration (FDA) that its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the Verigene® System has been categorized as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity. This categorization of the BC-GP test underscores the ease of use of the Verigene System and supports the decentralization of molecular testing.
"Decentralization of diagnostic tests that provide critical patient care information is of paramount importance in achieving improved outcomes and lower cost of care," said Nanosphere CEO Bill Moffitt. "We are committed to supporting our customers' needs as we expand our test menu and strive for flexible platform functionality. Our Verigene System has again achieved a notable milestone in that regard."
Nanosphere's BC-GP test is run on the Verigene System, an easy-to-use cartridge-based platform that enables rapid multiplex testing with sample-to-result automation in a near-patient setting. The Verigene BC-GP test provides genus and species level detection for a broad panel of clinically significant Gram-positive bacteria. In addition, the BC-GP test detects the mecA, vanA, and vanB genes that identify resistance