GAITHERSBURG, Md., Dec. 04, 2018 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN) announced today it has received
approval from the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia’s regulatory authority for food,
drugs, and medical devices, to market its rapid pathogen identification products in the country.
Earlier this year OpGen established a subsidiary, OpGen Colombia, SAS, to commercialize the Company’s precision medicine
products in Colombia and more broadly through South America. The approval of QuickFISH®, which is already cleared by the U.S. Food
& Drug Administration and identifies pathogens in 20 minutes in positive blood culture, is a significant milestone for the
Company’s expansion into the Latin American markets.
“We are proud to receive regulatory approval from INVIMA to begin the sale of our suite of QuickFISH pathogen
identification products in Colombia,” said Evan Jones, CEO, OpGen, Inc. “This milestone represents a significant step for the
Company as we seek to support our growth initiative in South America, and will serve as a market indicator for further expansion
and commercialization of our Acuitas® antibiotic resistance detection product offerings.”
The approval follows a successful study using QuickFISH. The study was conducted with Maria Virginia
Villegas, M.D, M.Sc., of Universidad El Bosque, the Bacteria Resistance and Hospital Epidemiology, Centro Internacional de
Entrenamiento e Investigaciones Medicas (CIDEIM), Cali, Colombia and four Colombian acute care hospitals. OpGen received positive
feedback from the hospitals and the study results, which demonstrated a 57% improvement in survival rate and reductions in
antibiotic usage for patients tested with the rapid diagnostic test, were presented at ASM Microbe 2018. Publication of
the study is expected in 2019.
OpGen continues its Center for Disease Control (CDC) funded collaboration to develop clinical support tools for
antimicrobial stewardship and infection control for low and middle-income countries. Evaluation of the new software is underway in
Colombia.
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, Acuitas, and QuickFISH are registered trademarks of OpGen, Inc.
Forward-Looking Statements
This press release includes statements relating to OpGen’s plans to commercialize its rapid pathogen
identification products in Latin American markets, starting in Colombia. 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
