NEW YORK (GenomeWeb News) – Nanosphere said after the close of the market Thursday that the US Food and Drug Administration has designated its Gram-Positive Blood Culture nucleic acid test as a moderate-complexity test under CLIA.
The test runs on the firm's Verigene System and provides genes- and species-level detection for a broad panel of clinically significant Gram-positive bacteria. It also detects the mecA, vanA, and vanB genes that identify resistance to the antibiotics methicillin/oxacillin and vancomycin.
"Moderate complexity" is a rating given by the FDA under CLIA to commercially marketed in vitro diagnostic tests based on their risks to public health. The designation enables Nanosphere to market the test to facilities, such as doctors' offices and clinics, that are cleared to run moderate-complexity tests.
"Decentralization of diagnostic tests that provide critical patient care information is of paramount importance in achieving improved outcomes and lower cost of care," Nanosphere CEO Bill Moffitt said in a statement. "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 received de novo clearance from the US Food and Drug Administration in June to market the BC-GP test.
The Verigene BC-GP test produces results in two and a half hours with less than 5 minutes hands-on time, according to Nanosphere, compared to 24-48 hours for results from microbiological culture techniques.