BARDA expands partnership with Hologic for development of a second high-throughput molecular assay for SARS-CoV-2

BARDA Response

BARDA expanded an existing partnership with Hologic, Inc., headquartered in Marlborough, Massachusetts, to accelerate development of the new Aptima® molecular assay to detect the SARS-CoV-2 virus in respiratory specimens.

Starting in late May, Hologic expects to begin producing at least one million Aptima® SARS-CoV-2 assays per week on average. The Aptima® SARS-CoV-2 assay runs on the Panther system, a fully automated, high-throughput molecular diagnostic platform that is widely used in the United States, with over 1,000 instruments installed across all 50 states. Each Panther system can provide initial results in less than three hours and process more than 1,000 coronavirus tests in a 24-hour period.

This molecular test is the second Hologic COVID-19 test to be supported by BARDA; the first was the Panther Fusion® SARS-CoV-2 assay which was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 16, 2020.

The SARS-CoV-2 diagnostic tests developed by Hologic, Inc. will increase testing capacity and expand access to testing in the U.S. to more rapidly identify, isolate, and treat those with COVID-19.

This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.


About Hologic: 
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment.