OpGen Completes Clinical Trials for its Initial FDA 510(k) Submission
The clinical trials tested more than 1,000 clinical isolates at four participating clinical sites: The
“We are pleased to have completed the isolate clinical trials as an important milestone toward submission for
The Acuitas AMR Gene Panel u5.47 is a new molecular test developed by OpGen designed to detect five key pathogens and 47 antibiotic-resistance genes semi-quantitatively in less than three hours. It is currently available for research use only (RUO). In addition to the isolate 510(k) submission,
There are more than one million patients each year in the U.S. with complicated UTI, and many of these patients are at risk for multidrug-resistant infections. Complicated UTI cases are a major cause of hospital admission, morbidity, mortality, and excess health care costs as a growing number of infections are healthcare-associated in origin.
The Acuitas AMR Gene Panel u5.47 (RUO) and the Acuitas Lighthouse Software (RUO) are intended for Research Use Only and are not for use in diagnostic procedures. The Acuitas Lighthouse Software is not distributed commercially for antibiotic resistance prediction and is not for use in diagnostic procedures.
This press release includes statements relating to OpGen’s regulatory submission timeline for 2019. 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
Source: OpGen, Inc.