Nanosphere, Inc., has announced the publication in PLOS Medicine of a prospective, multicenter study that company representatives say illustrates the high diagnostic accuracy and potential clinical impact of the company's FDA-cleared Verigene Gram-Positive Blood Culture (BC-GP) Test.
The study was authored by leading experts in microbiology and molecular diagnostics. It demonstrates the performance of the Verigene BC-GP Test in simultaneously detecting and identifying Staphylococcus aureus and 11 other gram-positive bacterial gene targets known to cause bloodstream infections and three genetic resistance determinants (the mecA, vanA, and vanB genes) directly from positive blood culture media. In addition, a retrospective analysis of turnaround time found that the Verigene BC-GP Test identified methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) species, two especially deadly causes of bloodstream infection, an average of 42 hours faster than reference methods.
Says Michael McGarrity, Nanosphere's president and CEO, ”These results validate the compelling value of the Verigene BC-GP Test in enabling rapid analysis and reporting of this time-critical, clinically actionable information to physicians. Our tests have been designed to work hand-in-hand with laboratory best practices to provide physicians with the optimal set of results for clinical decision making. We believe the Verigene System's ability to directly detect a comprehensive panel of bacterial DNA targets without the use of PCR is ideally and uniquely suited to the challenge of accurately identifying organisms in blood culture media.” Read the open-access article.