Prospective Study Demonstrates Accuracy and Potential Clinical Impact of Nanosphere's Verigene Gram-Positive Blood Culture Test

Prospective Study Demonstrates Accuracy and Potential Clinical Impact of 
Nanosphere's Verigene Gram-Positive Blood Culture Test 
Peer-Reviewed Manuscript Published in PLOS Medicine 
NORTHBROOK, IL -- (Marketwired) -- 07/02/13 --   Nanosphere, Inc.
(NASDAQ: NSPH), a leader in the development and commercialization of
advanced molecular diagnostics systems, today announced publication
of a prospective, multicenter study that illustrates the high
diagnostic accuracy and potential clinical impact of the company's
FDA-cleared Verigene(R) Gram-Positive Blood Culture (BC-GP) Test in
the peer-reviewed, open-access journal PLOS Medicine, published by
the Public Library of Science.  
The results reported in this manuscript, authored by leading experts
in microbiology and molecular diagnostics, demonstrate 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 turn-around 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.  
"The study concluded that the Verigene BC-GP Test is capable of
detecting the leading causes of gram-positive bacterial bloodstream
infections as well as genetic markers for methicillin resistance in
Staphylococcus aureus and vancomycin resistant Enterococcus directly
from positive blood cultures, and has the potential to markedly
reduce turn-around time for reporting," said Dr. Nathan A. Ledeboer,
Associate Professor of Pathology at the Medical College of Wisconsin. 
"We are very pleased these study results have been published in PLOS
Medicine, an evidence-based journal that focuses on diseases that
cause the greatest healthcare and economic burden worldwide," said
Michael McGarrity, Nanosphere's president and chief executive
officer. "These results are significant as they further validate the
compelling value of the Verigene BC-GP Test in en
abling rapid
analysis and reporting of this time-critical, clinically actionable
information to physicians. Our tests have been designed based on
comprehensive market feedback to work hand-in-hand with laboratory
best practices to provide physicians with the optimal set of results
for clinical decision making. Furthermore, 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." 
The manuscript, published under the title "Multiplex Identification
of Gram-positive Bacteria and Resistance Determinants Directly from
Positive Blood Culture Broths: Evaluation of an Automated
Microarray-Based Nucleic Acid Test," was composed by Blake W.
Buchan(1), Christine C. Ginocchio(2,3), Ryhana Manji(2), Robert
Cavagnolo(4), Preeti Pancholi(5), Lettie Swyers(5), Richard B.
Thomson Jr.(6), Christopher Anderson(6), Karen Kaul(6), and Nathan A.
With an impact factor of 16, PLOS Medicine is the leading open-access
medical journal, providing an influential venue for outstanding
research and commentary on the major challenges to human health
About Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test  
The Verigene(R) 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 faecium
 Staphylococcus aureus
 Staphylococcus lugdunensis
 Streptococcus pneumoniae 
Streptococcus anginosus group 
 Streptococcus agalactiae 
Streptococcus pyogenes 
mecA gene, conferring methicillin resistance
 vanA and vanB genes,
conferring 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 Nanosphere, Inc. 
Nanosphere develops, manufactures and markets an advanced molecular
diagnostics platform, the Verigene(R) System, for multiplexed
infectious disease, genetic, and ultra-sensitive protein testing.
This easy-to-use platform offers laboratories a convenient, simple,
and cost-effective solution for highly sensitive nucleic acid and
protein testing. Nanosphere is based in Northbrook, IL. 
For additional information regarding Nanosphere's infectious disease
products, please contact Nanosphere at or
1 Department of Pathology, Medical College of Wisconsin, Milwaukee,
Wisconsin, United States of America,  
2 North Shore-LIJ Health System, New York, New York, United States of
3 Hofstra North Shore-LIJ School of Medicine, Hempstead, New York,
United States of America,  
4 med fusion LLC, Lewisville, Texas, United States of America,  
5 Department of Pathology, The Ohio State University Medical Center,
Columbus, Ohio, United States of America,  
6 Department of Pathology; NorthShore University HealthSystem,
Evanston, Illinois, United States of America 
Except for historical information, the matters discussed in this
press release are "forward-looking statements" and are subject to
risks and uncertainties. Actual results could differ materially from
these forward-looking statements. Factors that could cause or
contribute to such differences include, but are not limited to, the
following: (i) Nanosphere's ability to develop commercially viable
products; (ii) Nanosphere's ability to achieve profitability; (iii)
Nanosphere's ability to produce and market its products; (iv)
Nanosphere's ability to obtain regulatory approval of its products;
(v) Nanosphere's ability to protect its intellectual property; (vi)
competition and alternative technologies; and (vii) Nanosphere's
ability to obtain additional financing to support its operations.
Additional risks are discussed in the Company's current filings with
the Securities and Exchange Commission. Although the Company believes
the expectations reflected in such forward-looking statements are
based on reasonable assumptions, it can give no assurance that its
expectations will be attained. The forward-looking statements are
made as of the date of this press release, and we undertake no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new i
nformation, future events or
Roger Moody 
Chief Financial Officer 
Nanosphere, Inc. 
Michael Rice
Founding Partner
LifeSci Advisors
Lindsey Saxon 
Director of Communications 
Nanosphere, Inc. 
Geoff Curtis
Press spacebar to pause and continue. Press esc to stop.