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Nanosphere, Inc.
, 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:
*Â 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.
*Â 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.
*Â 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.
*Â 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.
*Â 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.
*Â 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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