Wednesday June 24, 2020 0 comments
BOULDER -- MBio Diagnostics today announced it has been awarded a $629,595 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to develop and commercialize their point-of-care multiplex serology test for the detection of human anti-SARS-CoV-2 antibodies.
This support from BARDA will help MBio complete development of the panel and file for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), which would allow the 5-minute, quantitative point-of-care COVID-19 antibody test to enter the U.S. market, the company said.
Antibody tests (also known as serology tests) are used to assess an individual's immune response to SARS-CoV-2 viral infection. They are used to measure population prevalence, confirm an individual's prior COVID-19 infection, and for contact tracing of people in close contact with confirmed COVID-19 patients.
Only quantitative serology tests, such as MBio's COVID-19 Antibody Panel, could be used to assess if an individual has protective levels of IgG neutralizing antibodies, and if the levels are high enough to be a donor of convalescent plasma.
Most of the serology tests on the market use lateral flow technology that report results in 10-15 minutes and only report yes/no answers.
MBio's COVID-19 Antibody Panel measures two types of antibodies: IgM and IgG. The presence of IgM antibodies in blood indicates that the COVID-19 infection was likely within the last 30 days. IgG antibodies are measurable 10-14 days after symptoms appear, and likely provide some level of protection from re-infection.
Clinical trials are now underway to evaluate if plasma from recovered patients with sufficiently high titers of IgG neutralizing antibodies can be used therapeutically to treat critically ill COVID-19 patients.
The COVID-19 Antibody Panel potentially could be used to identify these high IgG recovered patients in a convenient point-of-care format.
"We are pleased to join the fight against COVID-19 and expand the capabilities of the LightDeck platform in partnership with BARDA," said Chris Myatt, MBio’s CEO.
"The funding will allow MBio to rapidly commercialize our first in vitro diagnostics product, the COVID-19 Antibody Panel."