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HeMemics Biotechnologies Receives HHS Support to Develop Rapid Antigen, Antibody Diagnostic to Identify COVID-19 Infected Individuals

HeMemics Biotechnologies Inc., announced that they are partnering with 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, on the development of a rapid, Bluetooth®-connected, easy-to-use test to diagnose COVID-19 in 60 seconds or less. The test detects SARS-CoV-2 and associated antibodies from nasal swabs or whole blood, meeting a critical need to distinguish between individuals with active infections and those who have developed antibodies to the virus.

The device is about the size of a cell phone, allowing for ease of use in both the field and in traditional care settings. More importantly, the technology can link the test results with cloud- based data management networks, allowing for real-time geographical mapping of outbreaks, or for instantaneous pre-travel screening at airports or ship terminals.

The Hememics device utilizes a multiplex chip that could simultaneously test for up to 17 different pathogens using a single drop of blood or nasal swab. Thus, the technology can test for diseases of interest that may present along with COVID-19 or can be used to confirm known or suspected disease status in patient populations.

BARDA will contribute $638,000 of the total estimated development costs, with Hememics providing the remainder. These funds will be utilized to adapt and test this technology as a rapid diagnostic tool for identification of COVID-19 via detection of antibodies Immunoglobulin G(IgG), Immunoglobulin M (IgM) and viral particles in people. Under this contract, Hememics will work with BARDA to establish manufacturing reproducibility, scale up production, and generate clinical data for FDA review of the immuno-biosensor platform.

"The development of a diagnostic device and test that can screen patients almost instantly in the field or in a healthcare setting will help people determine whether they can return to work safely, provide timely information to inform decisions about treatment, and provide data health officials need in their continuous efforts to mitigate the spread of infection during this pandemic and potentially in future coronavirus outbreaks," said BARDA Director Rick Bright, Ph.D.

"This is a great opportunity for Hememics to serve the health concerns of so many Americans who need rapid answers to guide care and treatment for this viral epidemic," said John Warden, CEO and co-founder of the Company. "Our technology has the potential to detect SARS-CoV-2 in under a minute, which will allow physicians and providers the ability to address the virus at the point of diagnosis, to improve patient care and outcomes."

David Ho, PhD, CSO and co-founder of the Company added, "We have been working for years to develop a platform that could be adapted in days and scaled in a few weeks to counter emerging epidemics such as COVID-19. The BARDA support will help us demonstrate the rapid utility of our device, as well as the broader networking capability to inform healthcare agencies and providers about outbreaks."

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. 75A50120C00074.

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