EMERYVILLE, Calif.--(BUSINESS WIRE)--Nanomix, a leader in the development of mobile, affordable, point-of-care diagnostics, today announced that the company has submitted an Emergency Use Authorization request to the U.S. Food and Drug Administration (FDA) for the eLab® COVID-19 rapid antigen test. The assay runs on the portable Nanomix eLab analyzer, which provides results in just 15 minutes and can be used in a wide range of settings, including hospitals, nursing homes, assisted living facilities, urgent care centers, and emergency medical care.
The Nanomix eLab platform and COVID-19 rapid antigen test will enable medical professionals, emergency workers, and employers to test individuals for antigens that indicate COVID-19 infection. The assay uses a nasal swab sample that can be self-administered, and is designed to complement existing test methods by expanding access to rapid, laboratory-quality results outside of hospital facilities.
“While the global healthcare community has made tremendous progress in COVID-19 testing, there is still significant need for rapid, accurate, and affordable testing that can be conducted outside of laboratory settings,” said David Ludvigson, president and CEO of Nanomix. “By completing this EUA filing, we are one step closer to making our antigen test available to help address this remaining gap.”
Nanomix previously validated and made available a rapid test for IgG and IgM antibodies that also runs on the eLab analyzer, and indicates past exposure to the SARS-CoV-2 virus.
Nanomix developed both the COVID-19 antigen and antibody assays in part with funding from BARDA.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00060.
Nanomix is a leader in the development of mobile point-of-care diagnostics, with a platform and assays that provide rapid, accurate, quantitative information for use in settings where time is critical to clinical decision making and improved patient care. The company’s products are designed to broadly impact health care delivery by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote, or alternative settings, thus enabling faster clinical decision-making and potentially treatment-in-place. Nanomix’s first assay addresses the critical need for faster sepsis diagnosis, and the company is developing a deep pipeline of other high-value tests where the rapid availability of high-quality diagnostic information can improve patient outcomes. For more information, visit www.nano.com.