OpGen launches molecular screen for antibiotic-resistant organisms

OpGen Inc. recently announced that it has launched a new molecular-based screening tool to quickly identify patients harboring multidrug-resistant organisms, including carbapenem-resistant Enterobacteriaceae.

According to the company, the Acuitas test can detect up to seven genes associated with MDR organisms (MDROs) from a single patient sample. Standard methods using microbial cultures can take up to 4 days to produce results. In addition, some molecular technology has demonstrated sensitivity greater than 95%. The quick turnaround of accurate results can direct appropriate therapy for patients and may assist hospitals in improving antimicrobial stewardship.

“Drug-resistant ‘superbugs’ pose a serious and immediate threat to the world’s health and safety, increasing the likelihood of prolonged illnesses, higher costs — even death,” Evan Jones, chairman and CEO of OpGen, said in a press release. “The new Acuitas MDRO gene test makes MDRO screening more efficient and cost-effective by delivering comprehensive, precise and actionable information to health care practitioners within 24 hours, assisting them in their efforts to combat and prevent the spread of these complex and potentially life-threatening infections.”

Among the bacteria the Acuitas test can identify are carbapenem-resistant Enterobacteriaceae (CRE) that contain KPC, NDM-1 and OXA-48 genes. The CDC estimates that nearly half of hospitalized patients who develop bloodstream infections from CRE bacteria will die of the infection. In 2013, CDC Director Thomas Frieden, MD, MPH, described these bacteria as a “nightmare,” and urged health professionals to collaborate and develop strategies to reduce CRE infections.

“This test reveals the genomic characteristics of the MDRO organism,” James W. Snyder, PhD, professor of pathology and laboratory medicine at the University of Louisville School of Medicine, told Infectious Disease News. “Genomic information or specific gene analysis is more definitive vs. culture, which is regarded as ‘phenotypic’ in nature. Phenotypic methods designed to classify the type of resistance — such as carbapenem resistance and extended-spectrum beta-lactamase resistance — do not reveal what gene is responsible for the resistance, ie, CTX-M19, KPC, NDM and others.”

James W. Snyder

Snyder said genomic information can be used to provide a more defined epidemiological database and improve tracking of the transmission of MDROs between patients.

Although the technology is new and has not been thoroughly tested in clinical trials, the information it generates “may influence more targeted antimicrobial therapy, including the possibility that an antibiotic is not needed, especially in patients who are colonized and not infected vs. broad-spectrum therapy,” he said.

The Acuitas test is currently being used at OpGen’s Clinical Laboratory Improvement Amendments-accredited clinical services laboratory in Gaithersburg, Md.

Disclosures: Snyder serves on the OpGen Advisory Board and the BioFire Defence, LLC Proxy Board.