Study Demonstrates Significant Clinical and Economic Impact of Nanosphere's Verigene Blood Culture Test

Nanosphere, Inc., a company enhancing medicine through targeted molecular diagnostics, today announced publication of a study in the Journal of Clinical Microbiology that evaluated the clinical and economic impact of rapid bacterial identification and antibiotic resistance determination by the Verigene® Gram-Positive Blood Culture (BC-GP) Test for patients with enterococcal bacteremia, which can lead to sepsis.

The manuscript reports that following implementation of Verigene BC-GP for the detection of bloodstream infections caused by Enterococcus, there was an average per patient reduction in hospital length of stay of 21.7 days, and an average savings of $60,729 in hospital costs.

In addition, there was a significant decrease in the average time it took for patients to receive appropriate treatment (23.4 hours), and an even greater reduction in time (31.1 hours) for patients with vancomycin-resistant Enterococcus (VRE) bacteremia -- an especially deadly cause of bloodstream infection and sepsis. Importantly, Verigene results enabled clinicians to immediately select appropriate therapy for 100 percent of patients with vancomycin-susceptible Enterococcus (VSE) bacteremia, potentially resulting in further cost savings.

Finally, there was complete agreement between BC-GP test results and those derived from conventional culture and susceptibility methods, along with a significant reduction in time to reporting of test results (47.5 hours).

"Minimizing time to appropriate antimicrobial therapy permits more effective targeting of the causative pathogens, decreases antimicrobial exposure, and can result in cost avoidance," said Yvette McCarter, PhD, D(ABMM), Director of Clinical Microbiology, University of Florida Health Jacksonville. "Utilization of assays such as the BC-GP test, supported by collaboration between microbiology and pharmacy, can optimize antimicrobial use, decrease unnecessary length of stay and costs, and improve time to appropriate therapy."

"We are very pleased with the study results as they demonstrate the significant clinical and economic value of Verigene in equipping antimicrobial stewardship teams with the information they need to recommend the best course of treatment for their patients," said Michael McGarrity, Nanosphere's president and chief executive officer. "A recent CDC landmark report highlighted the importance of improved antibiotic stewardship and the implementation of new diagnostic tests to aid in addressing the problem of antibiotic-resistant infections. As demonstrated in this study, Verigene has the ability to help hospitals meet this critical need, and the potential to improve patient outcomes, optimize antibiotic therapy, reduce costs and save lives."

Published ahead of print under the title "A Stewardship Approach to Optimize Antimicrobial Therapy Through Use of a Rapid Microarray Assay on Blood Cultures Positive with Enterococcus species," the study was performed at University of Florida Health Jacksonville. It is the first study to evaluate the clinical and economic impact of using rapid microarray technology on optimizing therapy for enterococcal bacteria.

About Verigene® Gram-Positive Blood Culture Nucleic Acid Test
The Verigene® Gram-Positive Blood Culture Nucleic Acid (BC-GP) Test performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection. These include the following organisms and antibiotic resistance markers:

Staphylococcus spp.
Streptococcus spp.
Listeria spp.
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus lugdunensis
Streptococcus pneumoniae
Streptococcus anginosus group
Streptococcus agalactiae
Streptococcus pyogenes

And

mecA gene (methicillin resistance)
vanA and vanB genes (vancomycin resistance)

The Verigene BC-GP Test is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. The Verigene BC-GP Test is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not to be used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, identify organisms not detected by the Verigene BC-GP Test, differentiate mixed growth, associate antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.

About the Verigene® System

The Verigene System uses core proprietary gold nanoparticle chemistry to offer highly sensitive, highly specific molecular diagnostic results through low-cost multiplexing. The Verigene System rapidly and accurately detects infectious pathogens and drug resistance markers by mapping the genome of a particular bacterium. Currently, Verigene assays target infections of the bloodstream, respiratory tract and gastrointestinal tract. The System also offers additional capabilities in cancer, cardiovascular disease and autoimmune disease. The information gathered from Verigene enables clinicians to identify diseases earlier and make informed patient treatment decisions more quickly, which may result in improved patient outcomes, reduced costs, optimized antibiotic therapy, reduced spread of antibiotic resistance and potentially, saved lives.