Avails Medical's eQUANT™ system submitted to FDA for 510(k) clearance

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Jun 12, 2023, 08:00 ET

MENLO PARK, Calif. , June 12, 2023 /PRNewswire/ -- Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions announced today the submission of its eQUANT^TM 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.

Rendering of Avails Medical’s single-slot eQUANT™ reader

"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," said Dr. Niaz Banaei, 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"' said Dr. Knopfmacher, 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." Avails Medical will showcase the eQUANT System as well as the eAST^TM System at the upcoming ASM conference in Houston in June (booth 1814).

In addition to FDA submission, Avails Medical also announced today 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.

Contacts:
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About Avails Medical, Inc.
Avails Medical was founded to address one of our greatest global health threats: antibiotic resistance. The Avails all-electrical technology is designed to significantly reduce the amount of time required to obtain the reliable antibiotic susceptibility data required to enable accurate therapy decisions. www.availsmedical.com

Acknowledgement and disclaimer
Research reported in this press release is supported by CARB-X. CARB-X's funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany's Federal Ministry of Education and Research (BMBF), and the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

SOURCE Avails Medical, Inc.