By Allison Proffitt
January 31, 2019 | These days, OpGen is focused on combating the global rise of antibiotic resistant pathogens. The company, which has a long history in sequencing technology, is now focused tightly on genes that confer antimicrobial resistance.
The Centers for Disease Control and Prevention estimate that antibiotic resistance causes more than 23,000 deaths each year in the U.S., and more than 2 million illnesses. Worldwide, the numbers are staggering: 700,000 people die each year from antimicrobial resistant infections. The CDC calls the problem one of the biggest health challenges of our time.
And yet, Evan Jones, CEO of OpGen, says most of these deaths could be prevented with better decision-making tools around antibiotics.
“What we have been working to build here at OpGen are informatics and genomic products that can help physicians rapidly make decisions in terms of what the right therapy is for a patient,” Jones says.
The company’s Acuitas AMR Gene Panel—developed through a discovery effort with Merck—looks at 47 antimicrobial resistance genes and five of the most causative pathogens for urinary tract infections. Clinicians can get the results of the DNA test within three hours; OpGen’s cloud-based Acuitas Lighthouse software interprets the findings.
OpGen is starting with urinary tract infections. There are nearly 10 million urinary tract infections in the US each year, Jones says, and 1.3 million of them are complicated UTIs (cUTI), many for patients in long-term care facilities or with other comorbidities. Infection quickly moves to the kidneys, then the bloodstream, and can be life threatening. About 20% of the complicated cases require treatment with “last resort” antibiotics, Jones says. “Finding those patients is complicated, expensive, and needs better tools.”
cUTIs aren’t the only common, dangerous infection type. Respiratory and blood infections are also common and can be deadly. cUTIs are a starting point because samples are easy to collect and test. “Respiratory samples, that’s one of the next ones we will tackle,” Jones says. “But that’s another level of complexity.”
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But OpGen’s platform has another use besides simply testing the patient before you; there is a public health application as well: helping hospitals manage their burden of these pathogens.
“You can view this as one technology with multiple applications,” explains Vadim Sapiro, Chief Information Officer at OpGen. “On the one hand, the test could be used in diagnostics to identify the pathogen and genes that are known confer specific types of resistance to specific types antibiotics. From those results, within three hours we can run a prediction to say what the susceptibility resistance patterns are for that specific pathogen: what to treat with, what not to treat with.
“However… the speed and resolution we’ve provided at the molecular level also allows us to do surveillance and hospital system type care in terms of what’s happening within a hospital ecosystem and not just to one patient,” he continues.
OpGen will be applying those capabilities to detect, track, and manage antimicrobial-resistant infections at healthcare institutions across New York.
In September, the New York State Department of Health launched a five-year partnership to develop a state-of-the-art research program for antimicrobial resistance. ILÚM Health Solutions, a wholly-owned subsidiary of Merck & Co. and OpGen will partner with the Wadsworth Center and DOH to develop an Infectious Disease Digital Health & Precision Medicine Platform, connecting healthcare institutions to DOH to better track and prevent the spread of infectious disease.
The first year will serve as a pilot of the program, deploying it in “three top health systems” across the state—Jones declined to name them. If the pilot is successful, then DOH, ILÚM and OpGen plan to expand the program throughout the state. The New York State Life Sciences Initiative will commit $22.4 million to this partnership.
“By investing in public health institutions and innovative research, we are working to protect New Yorkers against harmful infectious diseases while cementing our status as a leader in the growing life sciences sector,” said Governor Andrew Cuomo in a statement announcing the project. "This groundbreaking partnership will create new, cutting-edge tools to bring life-changing discoveries out of the lab and into the world, moving our economy forward and creating a stronger, healthier New York for all."
“The New York state project is set up to look for CREs [carbapenem-resistant Enterobacteriaceae], one of the prominent superbugs,” Jones explains. “When they find a CRE test result in the real time monitoring, our test will be triggered to be ordered for more additional information. It’s a very innovative initiative, not just to tackle this problem with the superbugs,” he says. “We are building an infrastructure with… ILÚM. And the infrastructure will monitor in real time the infectious disease test results for essentially every patient in the state.”
Submissions Forthcoming
OpGen expects 2019 to be a big year in another way as well. The company plans to submit a Class II 510(k) for the AMR Gene Panel isolates to FDA in the first quarter. Two more submissions will follow: one for a Class II 510(k) for the AMR Gene Panel urine and the other a Class II 510(k) for the Acuitas lighthouse software.
“These products, during 2019, will be submitted to the FDA and hopefully we’ll begin to see the first regulatory clearances,” Jones says. Pre-submission testing has been “quite a large endeavor”, Jones says. “We estimate that we’ve done about 5,000 tests in support of the first FDA submission… 1,000 of them are basically doing the whole genome sequence of the microbes.”