GAITHERSBURG, Md., April 19, 2018 (GLOBE NEWSWIRE) -- OpGen, Inc.(NASDAQ:OPGN) OpGen announced today that it successfully completed a prospective clinical trial evaluating the impact of using rapid diagnostic testing for identification and treatment of bacteremia and fungemia in hospital intensive care units in Colombia. The study showed significant improvement in survival and reductions in antibiotic usage for patients receiving the OpGen rapid diagnostic test. Results will be presented at the American Society for Microbiology ASM Microbe 2018 meeting this June.
The study was conducted with Maria Virginia Villegas, M.D., M.Sc., Bacteria Resistance and Hospital Epidemiology, Centro International de Entrenamiento e Investigationses Medicas (CIDEIM), Cali, Colombia and four Colombian acute care hospitals. Following the successful completion of the trial and positive hospital feedback, OpGen has established a subsidiary, OpGen Colombia, SAS, to commercialize OpGen’s precision medicine products in Colombia and more broadly through South America.
Evan Jones, OpGen Chairman and CEO, stated, “We were honored to be part of a regional prospective study demonstrating improved outcomes for patients with sepsis and other co-morbidities. We now have an established organization, leadership team and market data to support our growth initiative into South America.”
In September 2017, OpGen was awarded a U.S. Centers for Disease Control and Prevention (CDC) contract to develop clinical support tools for antimicrobial stewardship and infection control in low- and middle-income countries. Dr. Villegas and her team at the Universidad El Bosque (UEB) of Colombia are among the collaborators helping OpGen execute this one-year project which funded development and evaluation of cloud-based mobile software.
Mr. Jones added, “Our market entry into Colombia will be with our U.S. Food and Drug Administration-cleared QuickFISH® products. We anticipate completing the registration process with Colombia’s regulatory authorities and commencing product sales in the second quarter of 2018. Colombia will serve as a reference market for further expansion in the region and for the subsequent commercialization of our Acuitas® antibiotic resistance detection product offerings.”
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, Acuitas, and QuickFISH are registered trademarks of OpGen, Inc.
This press release includes statements relating to OpGen’s plans to commercialize its rapid diagnostic tests in Colombia and other countries in South America. 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.
LHA Investor Relations
Kim Sutton Golodetz
Source: OpGen, Inc.