Point-of-care diagnostics developer Nanōmix has submitted an Emergency Use Authorisation (EUA) request to the US Food and Drug Administration (FDA) for the eLab COVID-19 rapid antigen test.
The portable, handheld test delivers laboratory-quality results in 15 minutes in any setting to help expand access and availability of Covid-19 testing.
The assay runs on the portable Nanomix eLab analyser and can be used in various settings such as hospitals, nursing homes, assisted living facilities, urgent care centres as well as emergency medical care.
The Nanomix eLab platform and Covid-19 rapid antigen test will aid medical professionals, emergency workers and employers in testing people for antigens that indicate Covid-19 infection.
A self-administrable nasal swab sample is used by the assay and can complement present test methods by increasing access to rapid, laboratory-quality results outside of hospital setting.
Nanomix president and CEO David Ludvigson said: “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.
“By completing this EUA filing, we are one step closer to making our antigen test available to help address this remaining gap.”
Previously, Nanomix had validated and made available a rapid IgG and IgM antibody test that runs on the eLab analyzer and shows past exposure to the SARS-CoV-2 virus.
The company developed both the Covid-19 antigen and antibody assays with funding from US Biomedical Advanced Research and Development Authority (BARDA).
This development project is 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, and BARDA, Division of Research Innovation and Ventures.
In December, Evolve Manufacturing Technologies entered a partnership with Nanōmix to produce rapid antibody and antigen test kits for Covid-19.