NEW YORK – Avails Medical announced on Monday that it has submitted its eQUANT system to the US Food and Drug Administration for 510(k) clearance.
The Menlo Park, California-based firm also announced an additional $5.4 million in non-dilutive funding from CARB-X for its rapid eAST system after successfully achieving additional gating milestones.
The eQUANT system is an automated, fully electric system that provides an inoculum of 0.5 McFarland equivalents — a standardized measure of bacterial density in a liquid — directly from a positive blood culture in as little as 40 minutes.
The sample can then be used with traditional automated antimicrobial susceptibility testing systems and disk diffusion, reducing turnaround times by up to one day as compared to standard bacterial subculture methods, the firm said in a statement.
"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," Niaz Banaei, an investigator in a clinical study of the system and medical director of the Stanford Health Care clinical microbiology laboratory, said in a statement.
The eQUANT features a small footprint, an easy-to-use interface, and an affordable cost, according to Avails Medical. In a pilot study, the system achieved greater than 98 percent correlation to the subculture gold standard, the firm said.