Nanosphere's NSPH +0.50% Verigene BC-GP test, based on the company's proprietary array-based nanoparticle technology, demonstrated 100% sensitivity and specificity for detection of the drug-resistant bacteria MRSA and VRE, and an overall sensitivity of 98.4% for a broad panel of bacterial targets, according to an initial study.
The study, presented September 18 at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago was conducted by Dr. Nathan Ledeboer, Dr. Blake Buchan and colleagues at the Medical College of Wisconsin and Dynacare Laboratories in Milwaukee, WI.
Early laboratory identification of pathogenic bacteria in patients with bloodstream infections is critical to managing infections and improving patient outcomes. The benefits of faster diagnosis are well established and include increased survival rates, lower costs of patient care, and reduced use of unnecessary antibiotics. The automated BC-GP test returns results for 13 bacterial identification targets and 3 antibiotic resistance targets in under two and a half hours as compared with current microbiological culture methods that can take 24 -- 48 hours to identify bacterial pathogens and determine their resistance or susceptibility to common antibiotics.
The BC-GP test is part of Nanosphere's growing menu of infectious disease tests for the Verigene(R) platform. The Respiratory Virus Plus Nucleic Acid Test is an FDA-cleared, in vitro diagnostic test for respiratory viruses. Additional sample-to-result tests for gram-negative bacteria, C. difficile, and enteric pathogens are currently in development.
The study abstract, entitled "Evaluation of the Microarray-Based Sample-to-Result Verigene BC-GP Assay for Rapid Detection of Gram-Positive Bacteria and Resistance Determinants Directly from Positive Blood Cultures" can be accessed at http://www.abstractsonline.com/plan/AdvancedSearch.aspx and will be published through ASM Press at the conclusion of the conference.
This test is currently for investigational use only (IUO) and not for clinical diagnostic use; the performance characteristics of the test have not been established. The BC-GP test is currently pending CE-IVD and FDA review and clearance.
Nanosphere is using the power of nanotechnology to create innovative molecular diagnostics for the medical field. The Verigene(R) System is an easy-to-use cartridge-based platform that enables rapid, cost-effective, multiplexed testing in a near-patient setting. Current and forthcoming products include clinical diagnostics in the areas of infectious disease, pharmacogenetics, cardiology, and human genetics.