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FDA Authorization for Verigene Gram+ Blood Culture NAT

The FDA has granted Nanosphere, Inc. 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 significant 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 best treatment for bloodstream infections.

“With the BC-GP test, patients suspected of deadly infections can now get a first-ever diagnostic tool for detecting disease-causing bacteria while simultaneously determining antibiotic resistance within the critical timeframe for making and adjusting initial treatment,' said William Moffitt, Nanosphere's Chief Executive Officer.

The BC-GP test provides identification of bacteria and antimicrobial resistance genes from gram-positive blood culture bottles within two and a half hours, as compared with current microbiological methods, which can take up to two to three days.

Rapid and accurate identification of bacteria and resistance markers is critical in guiding appropriate antibiotic treatment. Studies show delayed administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour therapy is delayed.1 Rapid molecular testing of blood cultures reduces this time, with associated hospital cost savings of up to $21,000 per patient.2

The sample-to-result BC-GP test automates the steps of bacterial DNA extraction and target detection on the Verigene System.

The ease-of-use and fast turnaround time of the BC-GP test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing. In addition to its gram-positive blood culture test, Nanosphere is currently developing a test for gram-negative blood cultures that will provide genus, species, and resistance detection on the same automated platform. These tests are part of a comprehensive infectious disease test menu, including the multiplexed Verigene RV+ respiratory virus test cleared by the FDA in 2011, as well as tests for C. difficile and a panel of enteric bacterial and viral pathogens that Nanosphere plans to submit for FDA clearance in 2012.

References
1. Kumar A, Roberts D, Wood KE. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589-1596.

2. Bauer KA, West JE, Balada-Llasat J, Pancholi P, Stevenson KB, Goff DA. An antimicrobial stewardship program's impact with rapid polymerase chain reaction methicillin-resistant Staphylococcus aureus/S. aureus blood culture test in patients with S. aureus bacteremia. Clin Infect Dis. 2010;51(9):1074-80.

 


     
Tags: Blood Culture, Clostridium difficile, Identification, Respiratory Virus, Automation, Staphylococcus aureus, Pathogen, FDA, Staphylococcus

Date Published: August 28, 2012

Source article link: Nanosphere, Inc. » company contact details
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