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FDA Designates Nanosphere’s Verigene BC-GP Test as Moderate Complexity

Published on November 2, 2012 at 6:04 AM

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, 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 to the antibiotics methicillin/oxacillin and vancomycin.

Accurately identifying bacteria and resistance markers in a timely manner is crucial for guiding appropriate antibiotic therapy. Clinical studies have shown that faster results enable better patient outcomes and significant cost savings. Studies reveal the delay in administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour treatment is delayed.1 Rapid molecular testing of blood cultures has been shown to reduce this time and leads to a hospital cost savings of up to $21,000 per patient.2 While current microbiological culture techniques take 24-48 hours to identify bacterial pathogens and determine their resistance or susceptibility to common antibiotics, the Verigene BC-GP test produces results in two and a half hours with less than 5 minutes hands-on time.

The BC-GP test is part of a growing menu of infectious disease assays for use on the Verigene System. The Respiratory Virus Plus Nucleic Acid Test (RV+) is a FDA-cleared CLIA moderate-complexity in vitro diagnostic test for the detection of multiple respiratory viruses and virus subtypes. A sample-to-result test for C. difficile is pending 510(k) review by the FDA, while tests for Gram-negative blood cultures and enteric bacteria and viruses are currently in development.

Source: http://www.nanosphere.us

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