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), HHS announced Monday.
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).
"While the Centers for Disease Control and Prevention (CDC) 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," said BARDA Director Rick Bright.
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, HHS said in a statement. An EUA facilitates the availability and use of medical products needed during public health emergencies.
The test will be designed for use with Hologic’s Panther Fusion system, which is already in commercial use. The 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, HHS said.
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.
The FDA has issued emergency use authorizations of diagnostic tests from the CDC, other authorized public health laboratories, and for New York State's Wadsworth diagnostics test.
