OpGen Completes Clinical Trials for its Initial FDA 510(k) Submission
05 February 2019 - 11:30PM
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)
813-1284mfarmer@opgen.comInvestorRelations@opgen.com
Press Contact:Matthew BretziusFischTank
Marketing and PRmatt@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
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