COVID-19 News

HHS welcomes partners for COVID-19 diagnosis and treatment

Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide Mesa Biotech, Inc. of San Diego, California, with technical expertise and $561,330 in immediate funding to pursue eventual Food and Drug Administration (FDA) approval or clearance of a diagnostic test for COVID-19 infection.

Mesa Biotech’s test is the fourth COVID-19 molecular diagnostic to receive development funding from BARDA. The project was selected through a business-friendly EZ-BAA application process that streamlines the way BARDA collaborates with industry and entrepreneurs. BARDA’s EZ-BAA is open for molecular diagnostic tests that utilize platforms already cleared by the FDA, point-of-care tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and tests that detect COVID-19 disease; all submissions require a viable plan to meet the FDA’s EUA requirements.

In addition to the EZ-BAA, BARDA expanded its standard broad agency announcement to accept proposals for advanced development of diagnostics, vaccines, therapeutics and other medical products for use in the current COVID-19 public health emergency response and future coronavirus outbreaks.

To obtain information about products in development in the private sector that could be used in responding to COVID-19, the U.S. government launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies being developed for COVID-19.

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