Resisting antibiotic resistance

GAITHERSBURG, Md.—Aimed at fighting the rising resistance to antibiotics, diagnostics firm OpGen Inc. has joined a research collaboration with Merck, known as MSD outside of the U.S. and Canada, in developing new rapid diagnostics and information technology products to help combat the threat of antimicrobial resistance. The companies called it a “major undertaking” and noted that the partnership took many months of planning before launching their global effort in November 2016.

OpGen brings to the table its development of rapid DNA tests and a genomic knowledge base of antibiotic-resistant pathogens for predicting antibiotic susceptibility, while Merck provides access to its archive of over 200,000 bacterial pathogens gathered over the last 15 years through the Study for Monitoring Antimicrobial Resistance Trends (SMART), one of the world’s largest surveillance studies of antimicrobial resistance, supported by Merck in collaboration with International Health Management Associates (IHMA).

Per the terms of the collaboration, OpGen is performing genomic analysis, microbiology testing for drug resistance and incorporating this information into its Acuitas Lighthouse Knowledgebase and the development of rapid DNA tests. This new molecular testing and informatics approach is expected to help transform antibiotic decision-making for doctors managing acute care patients with blood, respiratory, urinary tract and soft tissue infections.

In addition to identifying resistance determinants to predict antibiotic failures, the OpGen technology is being evaluated as the foundation for utilizing molecular diagnostic tests to predict pathogen susceptibility and guide patient management choices to improve patient outcomes.

“This collaboration builds upon the promise of our DNA-based genetic tests, Lighthouse Knowledgebase and antibiotic resistance decision-making tools to make a significant impact on hospital infections,” states Evan Jones, chairman and CEO of OpGen. “Access to Merck’s SMART surveillance network data has the potential to greatly accelerate our internal development efforts in validating our rapid diagnostic tools and bolster data acquisition for our Lighthouse Knowledgebase.”

Jones adds, “Antimicrobial resistance is an increasingly serious threat to global public health. 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.”

In September 2016, “world leaders at the United Nations called rising antimicrobial resistance a fundamental threat to human health, development and security,” Jones says. “High rates of resistance have been observed globally in common bacteria (for example, Escherichia coli, Klebsiella pneumonia and Staphylococcus aureus) that cause common healthcare-associated and community-acquired infections (urinary tract infections, wound infections, blood stream infections and pneumonia).”

The use of antibiotics “is the single most important factor leading to antibiotic resistance around the world,” Jones tells DDNews. “Antibiotics are among the most commonly prescribed drugs and it is estimated that up to 50 percent of all antibiotics prescribed are not needed or are not optimally effective as prescribed.”

This research collaboration with Merck “is one of OpGen’s largest collaborations to date,” Jones says. “The project includes our performing molecular analysis on up to 10,000 pathogens from the Merck SMART surveillance network and using the results to help identify markers of resistance to support the development of our rapid diagnostic platforms and rapid decision-making capabilities using the Acuitas Lighthouse MDRO Management System.”

The process entails Merck “collecting pathogens for their SMART surveillance network from a large network of hospitals worldwide along with using our genomic testing pipeline,” he explains. “We anticipate completing more than one million individual genetic tests. Bringing all of this data together to help move the field forward is an exciting opportunity—and we are proud to be working with Merck on this important initiative.”

According to Jones, “During the first half of 2017, we anticipate completing the large-scale testing program and confirming results on panels of tests using clinical specimens collected from around the world. Assuming success with these activities, we will transition into early clinical testing for a product that can be used in hospitals in the U.S. and internationally, following appropriate regulatory clearances.”

Dr. Eliav Barr, senior vice president of infectious diseases and vaccines clinical development for Merck Research Laboratories, added: “By providing OpGen with access to our archive of bacterial pathogens, we hope to expedite the development of rapid diagnostic tests and enable prompt and informed antibiotic prescribing to improve patient outcomes.”