OpGen Issues Formal Response to FDA’s Requests for Additional Information and Expects Near Term FDA Clearance Decision for ...
October 13 2020 - 5:00PM
OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company
harnessing the power of molecular diagnostics and bioinformatics to
help combat infectious disease, announced today that it has issued
its formal response to the second of the FDA’s AI Requests
(Additional Information Request) for the Acuitas AMR Gene Panel
pre-market submission, addressing what OpGen believes to be all of
the FDA’s questions and open items.
OpGen had submitted a 510(k) Premarket
Notification for the Acuitas AMR Gene Panel for Isolates to FDA in
May 2019 and had subsequently received two formal AI Requests from
the agency; the first in July 2019 and the second in early 2020.
While a 180-day response deadline is normally imposed for these
requests, the OpGen response was delayed in June 2020 as
consequence of the COVID-19 pandemic when all pre-market
submissions on hold as of March 2020 were issued a 90-day extension
to the previously established response deadlines. During recent
weeks and months, OpGen has been working with the FDA review team
on an interactive basis to address any and all outstanding
information requests and has received numerous inputs and feedback
that have all been built into the formal response.
Johannes Bacher, COO of OpGen commented: “With
the successful and timely completion of our formal response we are
now eagerly awaiting the Agency’s final feedback and hope for a
swift FDA clearance decision in the coming weeks. We believe to
have a unique panel for a key healthcare threat in antimicrobial
resistance with unparalleled comprehensive coverage of genetic AMR
markers in the most relevant bacterial pathogens that are of key
concern in our hospitals today.”
Oliver Schacht, President and CEO of OpGen
added: “The Acuitas AMR Gene Panel is already being used for
testing isolates as part of a collaborative research project
looking at epidemiological surveillance by various major healthcare
facilities in New York State as part of a two-year strategic NY
State Department of Health collaboration project. Receiving FDA
clearance would allow us to make this available much more broadly
across the United States for tracking down and tracing outbreaks of
hospital superbugs and prevent them from spreading from one
hospital to the next.”
About OpGen, Inc.
OpGen, Inc. (Gaithersburg, MD, USA) is a
precision medicine company harnessing the power of molecular
diagnostics and bioinformatics to help combat infectious disease.
Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we
are developing and commercializing molecular microbiology solutions
helping to guide clinicians with more rapid and actionable
information about life threatening infections to improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs. OpGen’s product
portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas®
Lighthouse, and the ARES Technology Platform including ARESdb,
using NGS technology and AI-powered bioinformatics solutions for
antibiotic response prediction.
For more information, please visit
www.opgen.com.
Forward-Looking Statements
This press release includes statements regarding
OpGen’s Acuitas AMR Gene Panel for Isolates and its pending
submission for regulatory clearance with the U.S. FDA. 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 realization of expected benefits of our business combination
transaction with Curetis GmbH, the success of our commercialization
efforts, the impact of COVID-19 on the Company’s operations,
financial results, and commercialization efforts as well as on
capital markets and general economic conditions, 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:Oliver SchachtPresident and
CEOInvestorRelations@opgen.com
OpGen Press Contact:Matthew
Bretzius FischTank Marketing and PR matt@fischtankpr.com
OpGen Investor Contact:Megan Paul Edison
Group mpaul@edisongroup.com
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