NEW YORK (GenomeWeb) – Having recently completed a number of studies demonstrating the ability of its drug resistance profiling and bioinformatics technology for epidemiological tracking, OpGen is looking to make the case that it can be rolled out in hospital systems to help manage infections.
Over the last several years OpGen has focused on applying its technology for antimicrobial resistance profiling as well as building up a database of resistance profiles of organisms. It has used that technology to launch antimicrobial resistance profiling services from its CLIA laboratory as well as a software platform that can be used for surveillance. Through its acquisition of AdvanDx last year, the firm also sells infectious disease diagnostic tests based on peptide nucleic acid fluorescence in situ hybridization.
At the Infectious Disease Week conference last month in New Orleans, OpGen presented some preliminary results from retrospective and prospective studies it has done with hospitals and health systems. The firm discussed findings from a 900,000-patient retrospective study with Intermountain Healthcare to catalog infections, identify infection trends, and determine whether incorporating OpGen's diagnostic technology could reduce costs and improve patient outcomes. In addition, it conducted a prospective trial with the Department of Public Health in Washington, D.C., where it delivered data from its PCR-based drug resistance tests to 16 hospitals in real time through its Acuitas Lighthouse Management System.
These studies will be key to "set the stage" for OpGen as it looks to implement its technology into large hospital systems elsewhere in the US and to address the estimated $2 billion market opportunity in infectious disease and antibiotic resistance, Robert Lilley, OpGen's chief commercial officer, told GenomeWeb.
Evan Jones, OpGen's CEO, told GenomeWeb that the company is focused on developing not only rapid diagnostics and drug resistance profiling tests, but is also building up its database of microorganisms and developing bioinformatics tools that can be used for patient management decisions and surveillance. The goal is to provide its tests and software to hospitals that let them better treat and manage patients with drug resistant pathogens, he said.
The firm also recently struck a deal with Merck to develop diagnostics and informatics tools for antibiotic resistance.
Antimicrobial drug resistance has become an increasing public health concern in the US and around the world. According to the US Centers for Disease Control and Prevention, a 2015 study found that one particularly concerning organism, Clostridium difficile, caused nearly 500,000 infections and 15,000 deaths in the US in one year.
In order for hospitals to manage and understand these infections, it's important for them to know where they originate, the most common types of organisms present, and how they spread, Lilley said. For instance, he said, Intermountain Healthcare's management sensed a "shift" in how patients were becoming infected, Lilley said. Whereas 10 years ago, hospital-acquired infections were a major concern, many facilities have gone to great efforts to reduce the incidences of those infections to some success. For instance, according to the CDC between 2011 and 2014 there was a 13 percent decrease in hospital-acquired methicillin-resistant Staphylococcus aureus. And, between 2008 and 2014, there was a 17 percent decline infections from surgery.
"There's more of a recognition that carriers are coming in from outside the hospital," Lilley said, but not a clear picture of the types of organisms and where they are coming from. So, Intermountain and OpGen sought to understand the most common types of infections present within the hospital network and the source of those infections, and whether incorporating OpGen's tests and management system will lead to better outcomes and lower costs.
In the study with Intermountain, researchers first analyzed retrospective data from patients who had been diagnosed using standard culture-based techniques in order to understand the organisms present.
The researchers analyzed data from around 900,000 hospital admissions between January 2008 and December 2015. Overall, 1.4 percent of patients had infections that were resistant to at least one drug. Consistent with the recent CDC data, the researchers found that although MRSA was still the most common organism treated, its prevalence declined around 32 percent. And, while C. diff infections were relatively rare, their prevalence increased 222 percent. In addition, nearly 70 percent of the multidrug-resistant infections were not coming from the hospital setting, but from the ambulatory setting, Lilley said.
"The study really gave a map of where the infections were coming from," Evan Jones, OpGen's CEO, told GenomeWeb.
The OpGen and Intermountain team is still analyzing the data, and plans to present data next year on the cost of surveillance with OpGen's technology and what impact that would make on the cost of treating patients, for which there are a number of contributing factors, including hospital stay and treatment costs.
The goal is to see whether overall costs can be reduced through rapid diagnosis of the infection, determining whether it came from outside or inside the hospital, and identifying the drugs to which it is resistant. "I don't think that the costs of these resistant organisms has really been brought to attention," he said. They can be a huge burden on the hospital, particularly if patients have to be isolated and treated via dedicated staff, or a wide array of drugs must be tried to find one that works.
At ID Week, OpGen also presented preliminary data from a prospective study it did with 16 hospitals in the Washington, D.C., area. In this study researchers implemented OpGen's Acuitas Lighthouse Management System to look at the burden of multidrug-resistant organisms at 16 hospitals. That data will serve as a baseline from which the hospitals will be able to track infection trends, Jones said. It also serves as a proof of principal that OpGen's management system works and can be rolled out across large multi-hospital systems.
This study also featured OpGen's Acuitas MDRO Gene Test, which uses real-time PCR to detect 10 antibiotic resistance genes. Looking at carbapenem resistance in the 16 hospitals, the researchers found that from just over 1,000 consented patient samples, carbapenem-resistant Enterobacteriaceae were found in 5.1 percent of samples, including 4.8 percent of samples from acute care hospitals and 7.8 percent of samples from long-term care facilities. The data also allowed them to dig deeper into the sources of these infections. For instance, the team was able to determine that multiple patients within one hospital contained an identical DNA profile.
The infectious disease testing space has numerous players, and OpGen's products compete with those from BioMérieux, Roche, and Cepheid, among others. In addition, as costs for next-generation sequencing come down, researchers have begun looking at metagenomic sequencing approaches to diagnose infections. However, Lilley said such approaches are still only being used in limited cases, due to the cost and time associated with them. And, he said, metagenomic sequencing could be complementary to OpGen's PCR-based tests. In scenarios where the cause of the infection is truly unknown, metagenomic sequencing is a good approach to capture all possible candidates, he said. But, the reality is that the vast majority of infections are caused by a handful of organisms for which rapid testing would make the most sense.