NEW YORK – Mbio Diagnostics announced Tuesday it has received a $629,595 contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to develop and commercialize its point-of-care serology test for SARS-CoV-2 antibodies.
The Boulder, Colorado-based firm said the funds will support the further development of the COVID-19 Antibody Panel and the filing for Emergency Use Authorization with the US Food and Drug Administration. The antibody panel is MBio's first in vitro diagnostics product, CEO Chris Myatt noted in a statement.
MBio's quantitative point-of-care test measures IgM and IgG antibodies and returns results in five minutes, the company said. The test could be used to determine if a patient has protective levels of IgG antibodies and whether those levels are high enough for the patient to donate convalescent plasma, MBio added.
The firm's point-of-care LightDeck immunoassay platform uses a portable fluorescence analyzer and disposable multiplex test cartridges and is commercially available for veterinary diagnostics and environmental testing. MBio is also developing host-response panels for acute infections and sepsis, as well as cardiac marker panels for heart attack and heart failure, the firm said.
In April, MBio received $1.5 million in new funding from the US Defense Advanced Research Projects Agency to support clinical and regulatory activities before filings with the FDA.