March 18, 2020
HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections
In response to the now global pandemic, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), continues to work with its public-private partners to find solutions to mitigate the public health impact of the coronavirus disease 2019 (COVID-19). Part of this landscape is the immediate need for diagnostics tests that can quickly and accurately diagnose COVID-19 infections in order to identify the virus and mitigate the spread of the disease.
BARDA 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 its diagnostic test. With BARDA’s support, the company can complete the development work necessary to request Emergency Use Authorization (EUA) from the FDA for the Accula COVID-19 point-of-care test within two months of the award. The Accula COVID-19 diagnostic test requires minimal sample handling, and a 30-minute sample-to-result time.
“Diagnostics are a critical need in the overall strategy to fight this newest global public health threat. We need increased testing capacity in the U.S to rapidly identify, isolate, and treat those infected with COVID-19 in order to limit transmission of the virus, and we need those tests as close to the patients as possible,” said BARDA Director Rick A. Bright, Ph.D. “This partnership is the latest example of our strong commitment to make diagnostic tests available as quickly and broadly as possible for Americans. We are working tirelessly to advance multiple diagnostics to EUA status so healthcare providers can rapidly diagnose and treat patients with COVID-19.”
The Accula COVID-19 test will leverage Mesa Biotech’s Accula Dock instrument that is used with several 510(k)-cleared tests; FDA has categorized the Accula Dock influenza point-of-care test as Clinical Laboratory Improvement Amendments (CLIA) waived. Utilizing the Accula Dock, the new test will provide molecular results indicating the presence of the virus based on nasopharyngeal (back of the nose and throat) swab samples. The diagnostic test is intended for use in clinical and hospital laboratories.
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.
There are currently no FDA approved or cleared diagnostics, vaccines, or treatments for COVID-19. However, the FDA authorized emergency use of a several diagnostic tests under its EUA authority. HHS continues to work across the U.S. government to review potential products from public and private sectors to identify promising candidates that could detect, protect against or treat COVID-19 for development and FDA approval/clearance. HHS divisions, including the National Institutes of Health (NIH) and ASPR, are also supporting the development of multiple vaccines and therapeutic treatments for COVID-19.
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.
To shorten the time to apply for product licensure and to reduce the spread of COVID-19, federal agencies are particularly interested in identifying products and technologies that have progressed beyond non-clinical studies, have established domestic large-scale manufacturing capability with commercial Good Manufacturing Practices (cGMP), and have utilized a platform used to manufacture a product already cleared by the FDA.
About HHS, ASPR, and 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, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.