Avails Medical, a provider of rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions has announced the submission of its eQUANT system for FDA 510(k) clearance.

The eQUANT system provides a standardized inoculum (0.5 McFarland equivalent) directly from a positive blood culture, which is designed to be used with traditional automated AST systems and Disk Diffusion, accelerating routine AST turnaround times by up to one day.

“The global emergence of superbugs and rise in antimicrobial resistance is a leading public health concern. Providing clinical laboratories with rapid diagnostics is key to address this important challenge. eQUANT could have the potential to enable physicians to de-escalate from costly empiric, broad-spectrum antibiotics to an effective and lower cost therapy, a real game changer for patients,” says Niaz Banaei, MD, professor of Pathology and Medicine and medical director, Stanford Health Care Clinical Microbiology Laboratory and investigator in the clinical study.

The eQUANT system’s unique features include a very small footprint, easy-to-use user interface and affordable economics, making it well suited for widespread adoption. In a previous pilot study completed at two world-renowned clinical laboratories, the eQUANT system achieved >98% correlation when compared to the subculture gold standard.

“We are delighted to announce the important company milestone of FDA submission of the highly anticipated eQUANT system”‘ says Oren Knopfmacher, PhD, CEO of Avails Medical. “This is an important first step towards commercializing eQUANT in the U.S. and other countries. eQUANT can provide any clinical laboratory with a simple and powerful tool that is designed to fit seamlessly into the routine clinical laboratory’s workflow, accelerating traditional AST turnaround times by up to one day.”  

In addition to FDA submission, Avails Medical also announced an additional $5.4M million in non-dilutive funding from CARB-X for its rapid eAST system, after successfully achieving additional gating milestones. The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), is a global non-profit partnership based at Boston University dedicated to funding the development of new antibiotics, vaccines, diagnostics, and other products to address the rising global threat of antibiotic-resistant bacteria.

Featured image; Avails Medical has submitted its eQuant system to the FDA for 510(k) clearance. Photo: Avails Medical