Twelve Studies Presented at ASM 2014 Highlight New Performance and Clinical
Outcome Data Using Select Verigene Infectious Disease Tests
NORTHBROOK, Ill., May 21, 2014 (GLOBE NEWSWIRE) -- Nanosphere, Inc.
(Nasdaq:NSPH), a company enhancing medicine through targeted molecular
diagnostics, today announced that twelve studies evaluating the performance
and clinical impact of select Verigene® multiplex infectious disease tests
have been presented at the 114^th General Meeting of the American Society for
Microbiology (asm2014), held this week in Boston, Massachusetts.
In addition, during the meeting Nanosphere showcased Faces of Sepsis™, a video
recently launched by Sepsis Alliance, a non-profit patient advocacy
organization, which provides a glimpse into the touching stories of three
people whose lives have been affected by sepsis. This video was produced in
part with unrestricted support from Nanosphere.
"Antibiotic-resistant bacteria pose a serious threat to human and economic
health in the U.S., and significantly complicate the effective treatment of
life-threatening infectious diseases like sepsis," said Michael McGarrity,
president and chief executive officer of Nanosphere. "We believe our menu of
Verigene bloodstream infection tests offers a powerful solution to this
growing healthcare challenge, and are pleased with the growing body of
clinical evidence that demonstrates the critical impact they can have on the
quality of patient care and antimicrobial stewardship efforts in hospitals."
Following are summaries of several of the studies presented. Abstracts for the
remaining posters can be found at gm.asm.org.
*Poster 1141: "De-escalation of Antibiotics in Response to the Nanosphere
Verigene Gram-Positive Blood Culture Assay." This study compared patient
results and treatment before and after the Verigene Gram-Positive Blood
Culture Test (BC-GP) was implemented along with an automated result
reporting algorithm that included antibiotic recommendations for the
treating doctors. The test led to a 26 hour reduction in the time from
sample collection to the first dose of appropriate antibiotics for
patients with methicillin-sensitive Staphylococcus aureus (MSSA) and
vancomycin-resistant Enterococcus (VRE) infections. Additionally, the
percentage of patients placed on targeted therapy within 3 days of
collection increased from 62.8% in the pre-implementation group to 81.5%
in the post-BC-GP implementation group. The study was conducted at Baylor
University Medical Center and med fusion Laboratory (Dallas and
Lewisville, TX), led by Dr. S. Beal.
*Poster 1145: "Comparison of Verigene BC-GP to Peptide Nucleic Acid
Fluorescence in situ Hybridization (PNA-FISH) in Conjunction with mecA
Gene Detection for Staphylococcus aureus Bacteremia." In this study, each
of the 79 S. aureus isolates evaluated was correctly identified by both
Verigene BC-GP and PNA-FISH. Verigene BC-GP accurately distinguished
methicillin-resistant S. aureus (MRSA) from MSSA in all cases, while mecA
gene detection correctly distinguished 78 of 79 cases. Time to pathogen
identification and methicillin resistance determination was shortest by
Verigene BC-GP and both molecular methods provided more rapid results than
the phenotypic method, leading the authors to conclude that use of
Verigene BC-GP may lead to improved antibiotic use in patients with S.
aureus bacteremia compared to other platforms. The study was conducted at
Intermountain Healthcare (Salt Lake City, UT), led by Dr. B. K. Lopansri.
*Poster 1566: "Evaluation of the Nanosphere Verigene BC-GN for the
Identification of Gram-Negative Bacilli and Detection of Antibiotic
Resistance Mechanisms Directly from Positive Blood Cultures." In this
study, the Verigene Gram-Negative Blood Culture Test (BC-GN) correctly
identified 100% of gram-negative bacteria in 33 blood cultures and
correctly identified 13 out of 14 carbapenemase resistance markers.
Verigene BC-GN decreased the time to bacterial identification by a range
of 12 hours 21 minutes to 48 hours 18 minutes when compared to
conventional culture methods. In addition, review showed that medical
management could have been modified for 7 of 22 patients and the
antibiotic change could have been made by an average of 33 hours 26
minutes sooner as compared to acting on the results of conventional
culture identification. The study was conducted at Kaiser Permanente
Northwest (Portland, OR), led by J.T. Hill.
*Poster 1568: "Performance of the Nanosphere Verigene BC-GN Assay in an
Acute Care Inner-City Hospital." Verigene BC-GN successfully identified
the causative pathogen in 100% of the 65 patient cases tested in this
study. All resistance determinants were correctly identified based on
phenotypic and molecular comparison. In addition, Verigene BC-GN detected
organisms that produce the resistance enzyme CTX-M extended-spectrum
beta-lactamase (ESBL) in 3% of isolates tested, and identified 1 isolate
of Enterobacter species as an ESBL producer that would have otherwise gone
undetected by the laboratory. These results led the study authors to
conclude that Verigene BC-GN has the potential to detect ESBL and
carbapenem resistance determinants routinely encountered at their
institution. The study was conducted at Hennepin County Medical Center
(Minneapolis, MN), led by Dr. G. Hansen.
*Poster 1588: "Effects of Blood Volume on the Performance of the Verigene
BC-GP Assay in Pediatric Patients." For the 136 pediatric blood cultures
tested, Verigene BC-GP correctly identified 123 blood culture bottles with
mean blood volume of 1.5 milliliters (mL). For this data set, 93.8% of the
bottles containing greater than 3 mL of blood and 90.0% of bottles with
blood volume of less than 3 mL were successfully identified by Verigene
BC-GP. The 13 discordant results had blood culture bottles with a mean
blood volume of 1.7 mL. The authors conclude that obtaining adequate blood
volume is an ongoing challenge for the detection of pathogens in
bloodstream infections in pediatric patients; however, Verigene BC-GP is
highly robust with blood volume having no impact on overall performance
and blood volume. The study was conducted at Children's Hospital of Los
Angeles, led by Dr. C. M. Polanco.
*Poster 2533: "Decreasing Turnaround Times in Septic Patients Infected with
Carbapenemase Producing Gram-Negative Organisms, a First Look at an
Emerging Technology." In this study, sensitivity and specificity of
Verigene BC-GN were both 100% for each of the following organisms and
carbapenemase-encoding genes: bla[OXA23 ]containing A. baumannii, bla[VIM]
containing C. freundii, bla[NDM-1], bla[CTX-M-1 ]containing ATCC BAA2147
K. pneumoniae, bla[KPC ]containing E. cloacae, bla[KPC ]containing E.
coli, and bla[IMP ]containing K. pneumoniae[. ]The study was conducted at
San Antonio Military Medical Center (Fort Sam Houston, TX), led by E.
About the Verigene® System
The Verigene System uses Nanosphere's 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
targeting conserved genetic regions of a bacterium or virus. Currently, the
multiplexed Verigene assays target infections of the blood, respiratory tract
and gastrointestinal tract. The information gathered from Verigene test
results enables clinicians to make informed patient treatment decisions more
quickly, which may result in improved patient outcomes, reduced costs,
optimized antibiotic therapy, and reduced spread of antibiotic resistance.
About Nanosphere, Inc.
Nanosphere is enhancing medicine through targeted molecular diagnostics that
result in earlier disease detection, optimal patient treatment and improved
healthcare economics. The Company's versatile technology platform, the
Verigene® System, enables clinicians to rapidly detect the most complex,
costly and deadly infectious diseases through a low cost and simple-to-use
multiplexed diagnostic test. The combination of this innovative technology and
Nanosphere's customer-driven solutions keeps commitment to the patient at the
forefront of its business. Nanosphere is based in Northbrook, IL. Additional
information is available at http://www.nanosphere.us.
Roger Moody, Chief Financial Officer
Michael Rice, LifeSci Advisors
Lindsey Saxon, Director of Communications
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