March 13, 2020
HHS funds development of COVID-19 diagnostic tests
Two diagnostic tests that may detect severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in approximately one hour 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 Biomedical Advanced Research and Development Authority (BARDA) within ASPR will provide approximately $679,000 to DiaSorin Molecular, LLC of Cypress, California, to rapidly develop the Simplexa COVID-19 Direct Assay, and approximately $598,000 to QIAGEN LLC of Germantown, Maryland, to accelerate development of the QIAstat-Dx RPS2 test for COVID-19. The companies will provide the remaining funds for developing their respective diagnostic tests.
“Americans need access to rapid diagnostic testing. The sooner clinicians, patients, and public health officials know whether someone is infected with the novel coronavirus, the sooner they can take action to mitigate the spread of COVID-19,” said BARDA Director, Rick A. Bright, PhD. “Rapid diagnostic tests are critical in this public health response. We are working with the private sector at an urgent pace to make these tests available on as many diagnostic platforms as we can in the coming weeks.”
DiaSorin Molecular’s test will use a nasopharyngeal (back of the nose and throat) swab from patients and is being designed for use with the company’s Simplexa Direct technology, an FDA-cleared platform currently used for their influenza and Respiratory Syncytial Virus (RSV) tests.
The COVID-19 test would run on DiaSorin’s LIAISON MDX instrument, which works in conjunction with LIAISON MDX Studio software. This technology uses a sample-to-answer approach with minimal operator input; hundreds of the company’s diagnostic devices are in use in large commercial and hospital laboratories around the country. The COVID-19 test could potentially be ready within six weeks for Emergency Use Authorization (EUA) consideration by the U.S. Food and Drug Administration (FDA).
QIAGEN will develop a COVID-19 test, QIAstat-Dx RPS2, to be added to the QIAstat-Dx Respiratory Panel. The device is used to run FDA-cleared tests for 21 respiratory pathogens. The device features easy-to-use molecular testing with novel workflows. The COVID-19 test could be ready within 12 weeks for EUA consideration by the FDA.
Both development projects were selected through a business-friendly EZ-BAA application process that streamlines the way BARDA collaborates with industry and entrepreneurs. 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. However, the FDA issued emergency use authorization for diagnostic tests from the Centers for Disease Control and Prevention (CDC) and other authorized public health laboratories, and for use of New York State’s Wadsworth diagnostics test. In addition, FDA also issued a new policy Feb. 29 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, 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 potential therapeutic 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 novel coronavirus 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 manufacturing capability with commercial Good Manufacturing Practices (cGMP), 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.