GAITHERSBURG, Md., Feb. 05, 2019 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN) announced today that it has
completed the clinical trials needed to support its 510(k) submission for the detection of antimicrobial resistance genes in
bacterial isolates to the U.S. Food & Drug Administration (“FDA”) for clearance of its Acuitas® AMR Gene Panel u5.47 product.
The clinical trials tested more than 1,000 clinical isolates at four participating clinical sites: The Johns Hopkins University
School of Medicine; Wadsworth Center, New York State Department of Health; University Hospitals Cleveland Medical Center; and IHMA,
Inc. The company has completed the majority of analytical testing activities including reproducibility studies and DNA sequencing
of over 1,000 isolates to support the planned 510(k) submission.
“We are pleased to have completed the isolate clinical trials as an important milestone toward submission for FDA clearance of
our Acuitas AMR Gene Panel u5.47 product. We are encouraged by the preliminary results, and look forward to continuing the process
toward submission, as we seek clearance for use of our technology throughout the U.S.” said Evan Jones, CEO, OpGen, Inc.
The Acuitas AMR Gene Panel u5.47 is a new molecular test developed by OpGen designed to detect
five key pathogens and 47 antibiotic-resistance genes semi-quantitatively in less than three hours. It is currently available for
research use only (RUO). In addition to the isolate 510(k) submission, OpGen is conducting clinical trials in 2019 to support
a submission for direct-from-urine testing and the Acuitas Lighthouse® Software for antibiotic resistance prediction direct from
clinical samples and management of antimicrobial resistance data in healthcare institutions. These trials will test samples
collected from patients with urinary tract infections (UTI).
There are more than one million patients each year in the U.S. with complicated UTI, and many of these patients
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 treatment and prevention. The Acuitas Lighthouse Software (RUO) is the first
cloud-based software to predict antibiotic resistance, track antimicrobial resistance, and determine bacterial strain relatedness
in healthcare settings using bacterial genetic data. The Acuitas AMR Gene Panel (RUO) is the most comprehensive, rapid PCR
test for detecting five pathogens and 47 resistance genes which cover nine antibiotic classes. OpGen’s solutions will provide the
power to prescribe empiric therapy with precision. For more information, please visit www.opgen.com.
OpGen, Acuitas, and Acuitas Lighthouse are registered trademarks of OpGen, Inc.
The Acuitas AMR Gene Panel u5.47 (RUO) and the Acuitas Lighthouse Software (RUO) are intended for Research
Use Only and are not for use in diagnostic procedures. The Acuitas Lighthouse Software is not distributed commercially for
antibiotic resistance prediction and is not for use in diagnostic procedures.
Forward-Looking Statements
This press release includes statements relating to OpGen’s regulatory submission timeline for 2019. 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. Factors that could cause our results to differ materially from those described include, but are not
limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and
commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other
healthcare providers, the success of our commercialization efforts, the effect on our business of existing and new regulatory
requirements, and other economic and competitive factors. 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 Farmer
Vice President, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
Press Contact:
Matthew Bretzius
FischTank Marketing and PR
matt@fischtankpr.com
Investor Contacts:
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
