The Brava COVID-19 Antibody Panel to be Commercialized via Emergency Use Authorization

June 23, 2020 Boulder, CO  MBio Diagnostics, a company transforming point-of-care diagnostics with its next generation LightDeck® platform, 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.

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. The funding will allow MBio to rapidly commercialize our first in vitro diagnostics product, the COVID-19 Antibody Panel.”

Chris Myatt
CEO, MBio

About MBio Diagnostics

MBio Diagnostics is the innovator of the proprietary point-of care LightDeck platform that delivers highly sensitive, lab-quality results in minutes. The LightDeck platform consists of a robust, portable fluorescence analyzer and disposable, multiplex test cartridges. The test procedure is simple, enabling untrained users to perform testing on-the-spot. MBio is developing a portfolio of multiplex tests including panels for COVID-19, host-response panels for acute infections and sepsis and panels of cardiac markers for heart attack and heart failure. The LightDeck platform is also commercialized for veterinary diagnostics and for environmental testing. Learn more at www.MBioDx.com.

About BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 55 BARDA-supported products have achieved regulatory approval, licensure or clearance. To learn more about BARDA’s COVID-19 portfolio and partnering with BARDA, visit medicalcountermeasures.gov, and for more on federal support for the nationwide COVID-19 response, visit coronavirus.gov. 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, under Contract No. 75A50120C00130.

Contact

Carrie Mulherin
Chief Marketing Officer
267-496-6391 ● Carrie.Mulherin@MBioDx.com