OpGen Announces 1,000th Patient Sample Enrolled in Clinical Trial for Unyvero Urinary Tract Infection Panel
- Prospective multicenter trial for the Unyvero UTI panel recruited its 1,000th prospective patient sample
- Fourth trial site added to optimize enrollment for different sample types and accelerate trial completion
- Clinical performance evaluation aims at a subsequent FDA submission
“We’re pleased to see that the clinical trial has gained significant momentum after initial COVID-related challenges at the different participating trial sites in late 2021 and early 2022, as evidenced by the 1,000th patient sample now enrolled. This is a significant achievement towards the goal of 1,500 prospective samples as required by applicable FDA guidance”, said
“The UTI trial completion and final data read out, which we expect in the second half of this year, will be another major milestone for OpGen” commented
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This press release includes statements regarding OpGen’s clinical trial for its Unyvero Urinary Tract Infection panel. 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, the success of our commercialization efforts, 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 fact that we may not effectively use proceeds from recent financings, the continued realization of expected benefits of our business combination transaction with Curetis GmbH, the continued impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, our ability to satisfy debt obligations under our loan with the European Investment Bank, the effect of the military action in Russia and Ukraine on our distributors, collaborators and service providers, our liquidity and working capital requirements, 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.
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Source: OpGen, Inc.