Avails Medical, a developer of rapid, automated, and fully electrical antibiotic susceptibility testing (AST) technologies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new eQUANT system.
The eQUANT system provides a standardized inoculum (0.5 McFarland equivalent) directly from positive blood cultures. The clinical data submitted to FDA demonstrated eQUANT’s potential to reduce routine AST turnaround times by up to one day, meeting the high hurdle of over 95% correlation to standard-of-care methods, according to the company.
“To address the growing problem of antibiotic resistance, enhancing diagnostic speed in labs is vital and can save lives. In the trial, we found the eQUANT technology cut the time to find effective antibiotics by nearly a day, potentially enabling a quicker shift from broad-spectrum antibiotics to targeted treatments,” says Stefan Riedel, MD, PhD, associate medical director at Beth Israel Deaconess Medical Center, and clinical study investigator.
Avails eQUANT System
The eQUANT system is differentiated by its compact design, intuitive interface, and cost-effectiveness, qualities that position it well for broad adoption across a range of healthcare environments, including community hospitals, says Avails Medical.
“Our team has worked diligently to bring the eQUANT system to the market to meet a critical demand in clinical microbiology: accelerating the existing workflow to actionable AST results to improve patient care. Commercializing the eQUANT system is our first step towards achieving our mission of making rapid AST testing both affordable and accessible in all healthcare settings, significantly improving patient care and saving lives,” says Oren Knopfmacher, PhD, CEO and co-founder of Avails Medical.
Avails Medical also announced the appointment of Michael Blitz as executive vice president for Commercialization and Business Development. Blitz has more than 20 years of experience in the infectious disease IVD space bringing novel technologies to the market, the company says. He recently helped commercialize the Karius test and previously held commercial leadership positions at GenePOC, Nanosphere, and Meridian Bioscience.
Featured image: The eQUANT system. Photo: Avails Medical