OpGen Receives Regulatory Approval to Market Pathogen Identification Products in Colombia
December 04 2018 - 6:30AM
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)
813-1284mfarmer@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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