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Hologic to Receive $699K From BARDA for Rapid Development of High-Throughput Coronavirus Test

NEW YORK – The US Department of Health and Human Services said Monday it will provide advanced support for development of a Hologic molecular test for SARS-CoV2, the virus causing COVID-19.

HHS said the diagnostic assay ─ designed to process up to 1,000 tests in 24 hours ─ has been selected for development through a streamlined process called an easy broad agency announcement (EZ-BAA), which is managed by the HHS Office of the Assistant Secretary for Preparedness and Response's (ASPR's) Biomedical Advanced Research and Development Authority (BARDA).

The assay will run on the commercially available Panther Fusion system, which could provide results to clinicians in less than three hours, HHS said.

BARDA and Hologic expect that test development will be completed in weeks, allowing the US Food and Drug Administration to consider granting it an Emergency Use Authorization (EUA).

This Panther Fusion system, with sample-to-result automation, would allow for rapid scale-up of the COVID-19 diagnostic test if the FDA issues an EUA, HHS said.

"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 a statement. "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."

BARDA said it recently opened the EZ-BAA process for diagnostic tests that use platforms already cleared by the FDA and that have a viable plan to meet requirements for the FDA to consider EUA. BARDA added it has 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.