OpGen Completes Specimen Accrual and Testing in Acuitas® Clinical Verification Study
Study evaluated potential utility in management of complicated urinary tract infections; Analysis and peer-reviewed manuscript preparation are underway
GAITHERSBURG, Md., Nov. 06, 2018 -- OpGen, Inc. (NASDAQ: OPGN) today announced it has completed specimen accrual and testing of urine specimens for the clinical verification study with the Acuitas® AMR Gene Panel u5.47 (RUO) rapid diagnostic test and Acuitas Lighthouse® Software, which was initiated in March of this year.
The three participating clinical sites were Beth Israel Deaconess Medical Center, Geisinger, and Intermountain Healthcare. The results of the study, which tested 670 remnant urine specimens from patients at increased risk for complicated urinary tract infections (cUTI), will be summarized and discussed in a peer-reviewed manuscript anticipated to be published in 2019.
“We are pleased to have completed this important milestone with our renowned collaborators as we evaluate potential improvements in cUTI management. This study represents the first use of the Acuitas AMR Gene Panel u5.47 (RUO) in the hands of clinical laboratories – an important step forward for our technology,” said Terry Walker, Senior Vice President R&D, OpGen, Inc. “We are encouraged by the preliminary results of the study and we look forward to completing the analysis of the results from the use of our technology to evaluate these cUTI specimens. The publication should help demonstrate the accuracy of Acuitas Lighthouse predictions of antibiotic resistance for the pathogens most commonly found in complicated urinary tract infections in a peer-reviewed publication next year.”
The Acuitas AMR Gene Panel u5.47 is a new molecular test developed by OpGen designed to detect five key pathogens semi-quantitatively and 47 antibiotic-resistance genes in less than three hours. It is currently available for research use only.
There are an estimated 400,000 to 800,000 patients each year in the U.S. with cUTI, and approximately half 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.
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 and Acuitas are registered trademarks of OpGen, Inc.
This press release includes statements relating to the completion of specimen accrual and testing of urine specimens for the clinical verification study with the Acuitas® AMR Gene Panel u5.47 (RUO) rapid diagnostic test and Acuitas Lighthouse® Software. 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. 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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