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GAITHERSBURG, Md., Dec. 19, 2016 -- 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 [email protected] [email protected] OpGen Investor and Media Contact: MacDougall Biomedical Communications Cammy Duong 781-591-3443 [email protected]
