March 9, 2020
HHS Supports Development of First High-Throughput COVID-19 Diagnostic Test
A diagnostic test for coronavirus disease 2019 (COVID-19) - designed for use in a diagnostic system that can process up to 1,000 tests in 24 hours - will receive advanced development support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR).
The molecular diagnostic test from Hologic, Inc. becomes the first COVID-19 product selected for development through ASPR's Biomedical Advanced Research and Development Authority streamlined selection process, called an easy broad agency announcement (EZ-BAA).
"Early, rapid diagnosis is essential for clinicians and their patients to treat infections appropriately and take immediate action to help mitigate the spread of COVID-19," said BARDA Director Rick Bright, Ph.D. "While the Centers for Disease Control and Prevention and our nation's public health laboratories are making valiant efforts in testing and surveillance of coronavirus infections, these labs could become overwhelmed as the number of suspected cases grows. Rapid, high-throughput tests are critical to provide quick results for more Americans and to aid the nationwide public health response."
BARDA will contribute $699,000 to accelerate Hologic's development of a test that detects the genetic material of SARS-CoV-2, the virus that causes COVID-19. Test results could be available to clinicians in less than three hours.
BARDA and Hologic expect that necessary development will be completed in a matter of weeks which then would allow the U.S. Food and Drug Administration (FDA) to consider granting Emergency Use Authorization (EUA) for the diagnostic test. An EUA facilitates the availability and use of medical products needed during public health emergencies.
The test will be designed for use with the company's Panther Fusion system. The system is available today in commercial laboratories in the United States and other parts of the world.
This Panther Fusion system provides complete sample-to-result automation with minimal user interaction and offers a broad menu of FDA-cleared tests to detect common respiratory infections. This existing infrastructure and supply chain would allow for rapid scale-up of the COVID-19 diagnostic test if the FDA issues an EUA, which would increase access to testing for more U.S. patients and healthcare providers in the fight against COVID-19.
The business-friendly EZ-BAA application process streamlines the way BARDA collaborates with industry and entrepreneurs, enabling awards in as few as 30 days. BARDA recently opened the EZ-BAA for diagnostics that utilize platforms already cleared by the FDA, with a viable plan to meet requirements for the FDA to consider emergency use authorization. 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 emergency response and future coronavirus outbreaks.
There are currently no approved diagnostics, vaccines or treatments for COVID-19 infections. However, the FDA issued emergency use authorizations of diagnostic tests from the Centers for Disease Control and Prevention (CDC) and other authorized public health laboratories, and for New York State's Wadsworth diagnostics test. In addition, on February 29, FDA also issued a new policy to help expedite the availability of diagnostics.
HHS continues to work across the U.S. government, including with the Department of Defense, to review potential products from public and private sectors to identify promising candidates that could detect or protect against or treat COVID-19 for development and licensure. HHS divisions, including the National Institutes of Health (NIH) and ASPR, have begun supporting development of multiple vaccines and treatments for COVID-19.
To obtain information about any potential products in development in the private sector that could be used in responding to the COVID-19 outbreak, 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 commercial Good Manufacturing Practices (cGMP) manufacturing capability, and have utilized a platform used to manufacture a product already approved 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.