OpGen Releases Molecular Test for Hospital-Acquired Infections

OpGen, the Maryland-based clinical laboratory, has released a new molecular-based test that can identify patients at risk for harboring microbes that are highly resistant to antibiotics. The test, known as Acuitas, can be used to screen patients as they are admitted into hospitals and other care settings to ensure they do not spread difficult-to-control infections. Samples are taken with perio-anal swabs. OpGen can also test cultural isolates gathered by hospital infection control personnel. Altogether, Acuitas can detect seven genes that are directly involved with a variety of hospital-acquired infections (HAIs), including KPC, NDM, VIM, IMP, CTX-M, VanA, and OXA. Those genes are directly linked to carbapenem-resistant enterobacteriaceae, extended-spectrum beta-lactamase, and vancomycin-resistant enterococcus. It can detect 200 different subtypes within those genes. “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,” said Evan Jones, OpGen’s chief executive officer. One of the biggest selling points for the Acuitas assay is its turnaround time—the test can be performed at OpGen’s lab in Gaithersburg, Md., and results generated and transmitted within 24 hours. That compares to the current culturing and testing method of suspected infection sites that can take three or four days. Molecular testing for HAIs is a relatively new approach, but it is also being undertaken by hospital labs as well as stand-alone facilities. John T. Mather Memorial Hospital in Port Jefferson, N.Y., uses molecular testing to detect methicillin-resistant Staphylococcus aureus, better known as MRSA. The $25 test was able to drive down the rate of MRSA infection at the hospital from 14.8 cases per 1,000 discharges to 1.1 per 1,000 within three years of assaying patients. HAIs are a bane of the health care industry. A study published by Harvard University researchers last year concluded that HAIs cost the United States $10 billion a year, with most forms of the condition costing anywhere between $11,285 to more than $45,000 per patient to treat. The Centers for Disease Control and Prevention estimates that there are about 2 million cases of HAIs annually, a number many experts believe is underreported. The retail cost of an Acuitas test is less than $100, according to an OpGen spokesperson. OpGen declined to disclose projected volumes for Acuitas. Takeaway: The need to combat superbug infections in the hospital setting is driving new lab tests and speeding up turnaround times.