The Office of the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services’ (HHS) announced it will provide advanced development support to a diagnostic test for coronavirus disease 2019 (COVID-19) that can be used to process up to 1,000 tests in 24 hours. The test is being developed by Hologic, Inc. and is the first COVID-19 product to be supported through ASPR’s Biomedical Advanced Research and Development Authority (BARDA).
BARDA is contributing $699,000 to fast-track development of the test, which would produce results in less than three hours. The test is intended to be used with Hologic’s Panther Fusion system, an automated diagnostic testing system that offers a broad array of tests and requires minimal user interaction. The system is commercially available in many parts of the world including the U.S. Necessary development of the test is expected to be complete within a few weeks, at which time the Food and Drug Administration (FDA) could consider granting emergency use authorization (EUA).
BARDA recently opened an application process for diagnostics that utilize platforms already cleared by the FDA and have a feasible plan to meet requirements for EUA. BARDA is also accepting proposals for advanced development of diagnostics, vaccines, therapeutics and other medical products for the COVID-19 emergency response and future outbreaks.
Currently, there are no approved diagnostics, vaccines, or treatments for COVID-19 infections. However, the FDA issued EUA of diagnostic tests from the Centers for Disease Control and Prevention (CDC) and other authorized public health laboratories, as well as for New York State’s Wadsworth diagnostics test. The FDA also issued a new policy (WHG summary here) on February 29 to help hasten the availability of diagnostics.
HHS has also launched a website for private sector innovators and developers to submit information about any potential products they are developing that could be used in responding to the COVID-19 outbreak. The federal government is particularly interested in identifying products and technology 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.”