First large scale COVID-19 diagnostic test gets federal advanced development support

A new molecular diagnostic test created by Hologic, Inc. to quickly identify the virus that causes COVID-19 will receive advanced development support from the U.S. Biomedical Advanced Research and Development Authority (BARDA).

The test could theoretically be attached to a system capable of processing up to 1,000 tests in a day. It was selected for support by BARDA’s easy broad agency announcement selection process (EZ-BAA), making it the first COVID-19 product so chosen. In all, Hologic will receive $699,000 to accelerate its efforts on 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. “While the Centers for Disease Control and Prevention 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.”

While the number of tests in a day could reach 1,000, results could start coming back in under three hours. This rapid uptick in the analysis would allow clinicians to identify cases of SARS-CoV-2 infection more swiftly. Once development is completed, the U.S. Food and Drug Administration will consider granting Emergency Use Authorization for the test, allowing its unapproved use during the ongoing public health emergency, as there are currently no approved diagnostics, vaccines or treatments related to COVID-19.

The test is designed for use with Hologic’s Panther Fusion system, a largely automatic, commercial lab-capable system designed to detect common respiratory infections.