Diagnostics developer Nanomix today announced that it will receive roughly $570,000 from the Biomedical Advanced Research and Development Authority (BARDA), part of the office tasked with preparedness and response at the U.S. Department of Health and Human Services for the development and testing of COVID-19 point-of-care tests., which provides results in less than 15 minutes.
“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, in a press release. “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 COVID-19 assays will leverage the company’s the Nanomix eLab analyzer to detect either SARS-CoV-2 antigens or antibodies to SARS-CoV-2 for the identification of both active infections and previous exposure to the virus.
The company noted that the development of the antigen and antibody tests is intended to supplement current molecular-testing approaches for the virus while also increasing the number of people who can be tested in any given period and, because the eLab analyzer is portable, can allow for delivery of the test in multiple care settings.
The intention is to develop a test for patients presenting with non-specific respiratory symptoms that can distinguish SARS-C0V-2 from other coronaviruses, as well as common strains of the flu. Nanomix said it anticipates completing test development in June and will file for FDA Emergency Use Authorization shortly after development is completed.
“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., in a prepared statement
Nanomix conducted a similar project during the Ebola crisis, developing a test that simultaneously identified and differentiated Ebola, Dengue, and Lassa Fever, a test the company says it developed in eight weeks.
The Nanomix eLab Analyzer has received CE Mark for a multiple marker test for screening infections including sepsis and is currently undergoing 510(k) review by the FDA.