The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) is offering advanced development support to Hologic (NSDQ:HOLX) for a molecular diagnostic test for coronavirus (COVID-19).
Marlborough, Mass.-based Hologic’s test is the first coronavirus product selected for development through ASPR’s biomedical advanced R&D authority streamlined selection process (BARDA), which is called an easy broad agency announcement (EZ-BAA), according to a news release.
BARDA is set to contribute $699,000 to accelerate Hologic’s test development. The test is designed to detect the genetic material of SARS-CoV-2, the virus that causes COVID-19, and offer results to clinicians in less than three hours. The test is also set to be designed for use with Hologic’s Panther Fusion system, which provides sample-to-result automation.
Hologic and BARDA believe the development should be completed in a matter of weeks, which could allow the FDA to consider granting emergency use authorization (EUA) for the test.
“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,” BARDA director Rick Bright said in the news release. “While the [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.”
