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Nanosphere Announces Presentation of Six Studies, Data Shows Verigene BC-GN 99.2% Detection Sensitive to Toxins

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Nanosphere, Inc. (Nasdaq: NSPH), a company enhancing medicine through targeted molecular diagnostics, today announced that six studies performed by various U.S. and international medical facilities have been presented at the 24^th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) this week. These studies illustrate the unparalleled accuracy and demonstrated clinical utility of three Verigene® multiplex molecular infectious disease tests in both adult and pediatric patient populations. These include the Verigene Gram-Positive Blood Culture (BC-GP) (FDA-cleared; CE-IVD), Gram-Negative Blood Culture (BC-GN) (FDA-cleared; CE-IVD) and Enteric Pathogens (EP) (FDA clearance pending) Tests.

"We are excited to be showcasing further evidence of the accuracy, reliability and clinical value of our menu of multiplex molecular tests in the care of patients with infectious diseases," said Michael McGarrity, Nanosphere's president and chief executive officer. "Access to early and accurate diagnostic results is critical to healthcare providers' ability to determine the most appropriate course of treatment for their patients, particularly for infections of the bloodstream and gastrointestinal tract."

Presentations and posters showcased at ECCMID include:

* Presentation O264: "Accuracy and Potential Clinical Utility of Two Rapid Molecular Panels for Detection of Bloodstream Infection." The comparative study evaluated the performance of Verigene BC-GP and BC-GN versus the FilmArray Blood Culture Identification (BCID) assay from BioFire Diagnostics in detecting common bloodstream pathogens. When culture and MALDI-TOF identification along with automated susceptibility testing (Vitek2) were used as the gold standard, the overall sensitivity, specificity, positive and negative predictive values were 97.4%, 99.8%, 94.4% and 99.8% respectively for Verigene and 98.1%, 98.6%, 85.3% and 99.8% respectively for FilmArray. The FilmArray produced 26 positive results for Pseudomonas aeruginosa which could not be confirmed using culture; the authors considered these to be false positive results. The study was conducted at Guy's & St. Thomas' NHS Foundation Trust (London, United Kingdom) and GSTS Pathology (London, United Kingdom), and led by Dr. C. Ward. * Presentation O265: "Rapid Detection of Gram-Negative Bacteria and Resistance Determinants Directly from Positive Blood Cultures Using the Microarray-Based Sample-to-Result Verigene BC-GN Assay." This study found that among 125 monomicrobial cultures containing gram-negative bacteria, Verigene BC-GN was 99.2% sensitive in detection of bacterial identification targets present on the assay. The study was conducted at the Medical College of Wisconsin (Milwaukee (WI), USA), and led by Dr. N. Ledeboer. * Presentation O266: "Impact of the Verigene Gram-Positive Blood Culture Assay in a Tertiary Care Pediatric Hospital." This study found that rapid blood culture identification using Verigene BC-GP significantly decreased the time to organism identification and detection of resistance markers from 26.2 hours with traditional culture methods to 5.3 hours. This led to a reduction of 19.1 hours in the mean time-to-appropriate antimicrobial therapy among the study's pediatric patients. The study was conducted at Children's Hospital Los Angeles (Los Angeles (CA), USA), and led by Dr. S. Felsenstein. * Poster P0527: "Multi-Centre Evaluation of Verigene BC-GN Test for Rapid Detection of Gram-Negative Bacteria from Positive Blood Cultures from Pediatric Inpatients." This study found that Verigene BC-GN (RUO) correctly detected 72 of 73 blood cultures containing one of the following bacteria: Acinetobacter spp., Citrobacter spp., Enterobacter spp., E. coli, K. oxytoca, K. pneumonia, Proteus spp., P. aeruginosa or S. marcescens. The single miscall was a K. pneumoniae reported as Enterobacter spp. From this study, the authors conclude that Verigene BC-GN has the potential for a significant impact on the care of pediatric patients with Gram-negative sepsis. The study was conducted at Cincinnati Children's Hospital (Cincinnati (OH), USA), and led by Dr. J. Mortensen. * Poster P0541: "Potential Impact of a Microarray-Based Nucleic Acid Assay for the Rapid Detection of Gram-Negative Bacteria and Resistance Markers in Positive Blood Cultures." This study found that Verigene BC-GN results were available on average at 26 hours 5 minutes after blood draw, compared to 40 hours 5 minutes and 46 hours 5 minutes when using MALDI-TOF (VITEK MS) for bacterial identification and susceptibility testing (Vitek 2 AST-GN202 card), respectively. When considering ongoing empirical antibiotic therapy, the authors concluded that Verigene BC-GN performance would have allowed therapeutic adjustment approximately 14 hours earlier in 9 out of 14 patients with isolates featuring a carbapenem-resistant gene. The study was conducted at San Raffaele Hospital (Milan, Italy), and led by Dr. L. Infurnari. * Poster P0860: "Evaluation of the Verigene EP IUO Test for the Rapid Detection of Bacterial and Toxin Causes of Gastrointestinal Infection." This study found that for the 725 stool specimens tested, the total sensitivity and specificity of Verigene EP (IUO) for detection of common bacterial (Salmonella, Shigella, Campylobacter, Vibrio, Yersinia enterocolitica) and toxin (stx1, stx2) causes of gastrointestinal tract infection when compared to traditional culture methods was greater than 98.5%. With these findings, the authors concluded that rapid diagnostic tests that accurately detect the bacterial and toxin-related cause of gastroenteritis can potentially improve patient management decisions to avoid unnecessary or inappropriate treatment. The study was conducted at Kaiser Permanente (North Hollywood (CA), USA), and led by Dr. S. Novak-Weekley.

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