The Nanomix COVID-19 assays detect either SARS-CoV-2 antigens or antibodies to SARS-CoV-2 to identify both active infections and previous exposure to the virus. The portable Nanomix eLab analyzer can be used in a wide range of settings, including hospitals, nursing homes, assisted living facilities, urgent care centers and emergency medical care.
“Accurate, rapid and mobile testing is critical to slow the spread of COVID-19 and reduce the devastating impact of this pandemic on the United States and the rest of the world,” said David Ludvigson, president and CEO of Nanomix. “We are thankful that the U.S. government is supporting our work to develop tests that are needed to battle SARS-CoV-2 in our communities and could help people safely and confidently return to work and other critical functions.”
The Nanomix approach can enhance current COVID-19 molecular-testing approaches and greatly increase the number of people who can be tested in any given period. The new assays will be able to distinguish SARS-CoV-2 from other coronaviruses, as well as a common flu strain, to aid in the diagnosis of patients with non-specific respiratory symptoms. The company expects to complete development in early June and file for Emergency Use Authorization shortly afterward.
“With a virus that may be spread by asymptomatic people, a rapid point-of-care platform that informs people if they have an active infection or had previously been infected is the key for many to returning to daily living,” said BARDA Director Rick Bright, Ph.D.
Nanomix conducted a similar project during the Ebola crisis, developing a test that simultaneously identified and differentiated Ebola, Dengue, and Lassa Fever. Nanomix developed that test in eight weeks and successfully completed field testing with the resulting assay.
The Nanomix eLab Analyzer has received CE Mark for a multiple marker test for screening serious infections including sepsis and is undergoing 510(k) review for clearance by the U.S. Food and Drug Administration (FDA).
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.