OpGen Supports Passage of Landmark 21st Century Cures Act to Expedite Development of Solutions for Bacterial Infections
December 19 2016 - 3:30PM
OpGen, Inc. (NASDAQ:OPGN) issued the statement below following the
passage of the 21st Century Cures legislation in support for
advancing medical breakthroughs to meet some of the biggest
healthcare challenges today. The statement can be attributed to
Evan Jones, Chairman and CEO of OpGen:
“The passage of this historic legislation provides important
improvements in the regulatory framework for drugs, diagnostics,
and information products to combat the rise of antibiotic resistant
infections. The 21st Century Cures Act creates a new approval
pathway for antibacterial and antifungal drugs intended to treat
serious life threatening infections in limited populations of
patients for which there is an unmet medical need. Infections with
many of the most drug resistant pathogens potentially fall within
this category of patients.
The Act makes improvements in the regulation of medical and
decision support software, and for identifying and updating
antibiotic susceptibility test interpretive criteria. We believe
these improvements will help manufacturers respond more quickly to
the rising global threat of antibiotic resistance. The Act also
creates requirements for resources to address education,
development, and implementation of antibiotic stewardship
programs.”
“On a broader scale, this legislation provides $4.8 billion in
additional funding over ten years to the National Institutes of
Health (NIH) to support the Precision Medicine Initiative, and
advances in personalized medicine. The bill also provides $500
million to the FDA to help streamline the way the agency approves
drugs and medical devices. We applaud the authors of this landmark
legislation, the Senate, U.S. House of Representatives, and the
President for enacting this legislation.”
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. Learn more at www.opgen.com and
follow OpGen on Twitter and LinkedIn.
OpGen, Acuitas, Acuitas Lighthouse and QuickFISH are
registered trademarks of OpGen, Inc.
OpGen Contact:
Michael Farmer
Director, Marketing
240-813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
OpGen Investor and Media Contact:
MacDougall Biomedical Communications
Cammy Duong
781-591-3443
cduong@macbiocom.com
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