GAITHERSBURG, Md., Feb. 13, 2018 (GLOBE NEWSWIRE) — OpGen, Inc. (NASDAQ:OPGN) announced today that it has entered into a global supply agreement to use Thermo Fisher Scientific’s real-time PCR technology in the company’s Acuitas® AMR Gene Panel Tests. The first test, the Research Use Only (RUO) AMR Gene Panel u5.47, is available for infection control purposes and pharmaceutical surveillance research. OpGen is planning clinical trials to support regulatory submissions for broader clinical use in patients with complicated urinary tract infections (cUTI).
Recent studies have indicated that antimicrobial resistant infections currently claim 50,000 lives each year across the United States and Europe alone, with many hundreds of thousands more dying in other areas of the world. OpGen is addressing this global threat with innovative technologies that enable rapid and precise identification of antimicrobial resistance.
Effective, targeted antimicrobial treatment is of critical importance in patients with cUTI and other serious infections as the emergence and spread of antimicrobial-resistant organisms increase. 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 continues to be 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 new Acuitas AMR Gene Panel u5.47 RUO test detects 47 gene targets which span 600 subtypes and convey resistance to 9 classes of antibiotics directly from urine and isolated colonies. From urine specimens, the Acuitas AMR Gene Panel u5.47 RUO will semi-quantitatively detect the most common bacterial causes of cUTI (E. coli, K. pneumoniae, P. aeruginosa, P. mirabilis, E. faecalis). Test results are provided in under three hours compared with traditional microbiology methods, which can take two to three days.
In an easy-to-use laboratory protocol, the Acuitas AMR Gene Panel u5.47 RUO test will incorporate Thermo Fisher’s TaqMan® Fast Advanced Master Mix and TaqMan® Probes for quick, multiplexed gene detection. The genetic results may be analyzed in OpGen’s Acuitas Lighthouse® Knowledgebase bioinformatics system to help healthcare providers rapidly and accurately identify antimicrobial resistance.
“We are pleased to expand our relationship to include these market-leading real-time PCR technologies. In 2017 we entered into an agreement to use the QuantStudio™ 5 Real-Time PCR System. The combination of these technologies, along with OpGen’s innovative solutions, will aid laboratories and healthcare providers in the fight against antimicrobial resistance,” said Evan Jones, Chairman and CEO of OpGen. “Thermo Fisher’s market-leading position in PCR and its global installed base makes it an ideal partner for our Acuitas Rapid Test.”
TaqMan® Fast Advanced Master Mix, TaqMan® Probes and QuantStudio™ 5 Real-Time PCR System are for research use only and are not intended for diagnostic procedures.
OpGen, Inc. is harnessing the power of informatics and genomic analysis to provide complete solutions for patient, hospital and network-wide infection treatment and prevention. Learn more at www.opgen.com and follow OpGen on Twitter and LinkedIn.
OpGen, Acuitas, and Acuitas Lighthouse are registered trademarks of OpGen, Inc. All other trademarks are properties of their respective owners.
This press release includes statements relating to OpGen’s Acuitas Rapid Test in development and its Acuitas Lighthouse Knowledgebase in development and its commercialization plans for these products. 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 OpGen’s business, please review our filings with the Securities and Exchange Commission (SEC). 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.