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 (BARDA) streamlined selection process, called an Easy Broad Agency Announcement (EZ-BAA).
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.