OpGen Inc, a molecular diagnostics company based in Gaithersburg, Md, has launched a new molecular-based test that can quickly and reliably identify patients at risk for harboring serious disease-causing microbes that can resist even the strongest antibiotics.
The Acuitas MDRO gene test is a comprehensive molecular screening tool that can directly detect as many as seven genes from one patient sample, and will help hospitals and public health officials combat some of the most critical multidrug resistant organisms (MDROs) threatening patients in healthcare facilities.
“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 chairman and CEO. “The new Acuitas MDRO gene test makes MDRO screening more efficient and cost-effective by delivering comprehensive, precise, and actionable information to healthcare practitioners within 24 hours, assisting them in their efforts to combat and prevent the spread of these complex and potentially life-threatening infections.”
Each year, more than two million Americans get infections that are resistant to antibiotics. Of those, up to 23,000 die. The Infectious Disease Society of America (IDSA) reports that infections caused by drug-resistant gram-negative bacteria are increasing, and preservation of the limited supply of effective antibiotics is only possible through strong antibiotic stewardship and infection prevention programs. Infections with superbugs such as carbapenem-resistant Enterobacteriaceae (CRE) have spread rapidly throughout the world in the past decade, with prevalence increasing throughout the Far East, the Middle East, Europe, South America, and North America, leaving some regions in endemic states.
Unlike current microbe detection methods based on growing cells in laboratory culture (a process that can take up to four days and can miss patients at risk for being colonized), the Acuitas test uses highly sensitive molecular technology to detect antibiotic-resistant genes within 24 hours. It can distinguish specific genes that may aid in therapeutic guidance. Molecular technologies have been shown to have sensitivity greater than 95%, better assuring that at-risk patients are not missed.
The Acuitas test detects genes associated with some of the world’s most deadly bacteria, including CRE and its component genes KPC, NDM-1, and OXA-48. Those genes are resistant to nearly all antibiotics, including carbapenems, a broad spectrum class of antibiotics considered to be the last resort for serious gram-negative bacterial infections. In critical care settings, death rates from KPC patients often exceed 50%. In 2013, the US Centers for Disease Control and Prevention identified CRE infection as an urgent public health threat requiring immediate and aggressive action.
“The Acuitas MDRO gene test is a significant development in our efforts to maintain the safety of patients against multidrug resistant organisms, said James W. Snyder, PhD, professor of pathology and laboratory medicine at the University of Louisville School of Medicine. “The strength of this technology is based on the more-accurate genomic approach to the detection of highly transmissible genes as opposed to traditional bacterial culture. In addition, it can help to identify those patients who harbor MDROs, which may increase their risk for infection.”
“This test will provide the most comprehensive and precise MDRO information in the shortest time with an aim to improve antibiotic stewardship programs, increase the effectiveness of infection and outbreak prevention, and improve patient outcomes,” said Terry Walker, PhD, OpGen vice president for R&D.