A preliminary study reveals that Nanosphere’s Verigene BC-GP test that utilizes the company’s patented array-based nanoparticle technology has illustrated 100% specificity and sensitivity for identifying the drug-resistant bacteria VRE and MRSA and 98.4% of overall sensitivity for a wide range of bacterial targets.
The study results were presented at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy conducted in Chicago on September 18 2011. The BC-GP test is one of the infectious disease tests of Nanosphere for the Verigene platform. The respiratory virus plus nucleic acid test is FDA-approved for vitro diagnostic tests in order to detect respiratory viruses.
Nanosphere currently develops more sample-to-result tests for C. difficile, gram-negative bacteria and enteric pathogens. Early laboratory detection of pathogenic bacteria in patients suffering from bloodstream infections is important to keeping infections in check and enhancing patients treatment. The advantages of quicker diagnosis are broadly recognized and comprise reduction in patient care costs, improved survival rates and reduction in the utilization of unwanted antibiotics.
The automated BC-GP test delivers results for 3 antibiotic resistance targets and 13 bacterial identification targets within 2.5 hours when compared to existing microbiological culture techniques that require 24 to 48 hours to detect bacterial pathogens and identify their susceptibility or resistance to general antibiotics. At present, this test is only for investigational use and not for clinical diagnostic. The performance qualities of the BC-GP test have not been confirmed. FDA and CE-IVD review and clearance is currently pending for the test.