OpGen Completes Specimen Accrual and Testing in Acuitas® Clinical Verification Study
November 06 2018 - 7:30AM
Study evaluated potential utility in
management of complicated urinary tract infections; Analysis and
peer-reviewed manuscript preparation are underway
OpGen, Inc. (NASDAQ: OPGN) today announced it has
completed specimen accrual and testing of urine specimens for the
clinical verification study with the Acuitas® AMR Gene Panel u5.47
(RUO) rapid diagnostic test and Acuitas Lighthouse® Software, which
was initiated in March of this year.
The three participating clinical sites were Beth
Israel Deaconess Medical Center, Geisinger, and Intermountain
Healthcare. The results of the study, which tested 670 remnant
urine specimens from patients at increased risk for complicated
urinary tract infections (cUTI), will be summarized and discussed
in a peer-reviewed manuscript anticipated to be published in
2019.
“We are pleased to have completed this important
milestone with our renowned collaborators as we evaluate potential
improvements in cUTI management. This study represents the
first use of the Acuitas AMR Gene Panel u5.47 (RUO) in the hands of
clinical laboratories – an important step forward for our
technology,” said Terry Walker, Senior Vice President R&D,
OpGen, Inc. “We are encouraged by the preliminary results of the
study and we look forward to completing the analysis of the results
from the use of our technology to evaluate these cUTI specimens.
The publication should help demonstrate the accuracy of Acuitas
Lighthouse predictions of antibiotic resistance for the pathogens
most commonly found in complicated urinary tract infections in a
peer-reviewed publication next year.”
The Acuitas AMR Gene Panel u5.47 is a new
molecular test developed by OpGen designed to detect five key
pathogens semi-quantitatively and 47 antibiotic-resistance genes in
less than three hours. It is currently available for research use
only.
There are an estimated 400,000 to 800,000
patients each year in the U.S. with cUTI, and approximately half
are at risk for multidrug-resistant infections. Complicated UTI
cases are a major cause of hospital admission, morbidity,
mortality, and excess health care costs as a growing number of
infections are healthcare-associated in origin.
About OpGen
OpGen, Inc. is harnessing the power of
informatics and genomic analysis to provide complete solutions for
patient, hospital and network-wide infection prevention and
treatment. For more information, please visit
www.opgen.com.
OpGen and Acuitas are registered trademarks
of OpGen, Inc.
Forward-Looking Statements
This press release includes statements relating
to the completion of specimen accrual and testing of urine
specimens for the clinical verification study with the Acuitas® AMR
Gene Panel u5.47 (RUO) rapid diagnostic test and Acuitas
Lighthouse® Software. These statements and other statements
regarding OpGen’s future plans and goals constitute
"forward-looking statements" within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, and are intended to qualify for the safe
harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Such statements are subject to risks
and uncertainties that are often difficult to predict, are beyond
our control, and which may cause results to differ materially from
expectations. For a discussion of the most significant risks and
uncertainties associated with OpGen's business, please review our
filings with the Securities and Exchange Commission. You are
cautioned not to place undue reliance on these forward-looking
statements, which are based on our expectations as of the date of
this press release and speak only as of the date of this press
release. We undertake no obligation to publicly update or revise
any forward-looking statement, whether as a result of new
information, future events or otherwise.
OpGen Contact:Michael FarmerVice President,
Marketing(240)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Press Contact: Matthew Bretzius FischTank
Marketing and PRmatt@fischtankpr.com
Investor Contacts:LHA Investor RelationsKim
Sutton Golodetz(212) 838-3777kgolodetz@lhai.comorBruce Voss(310)
691-7100bvoss@lhai.com
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