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U.S. Department of Health and Human Services

Hologic, Inc. – Aptima® SARS-CoV-2 Assay

ASPR’s Portfolio of COVID-19 Medical Countermeasures under EUA

The Aptima® SARS-CoV-2 assay is a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease, in respiratory specimens. This assay is being developed for use on the Hologic Panther System which is a fully automated, high-throughput molecular diagnostic platform with over 1,000 instruments installed in the U.S.

Funding will be used to support the continued development of the Aptima® SARS-CoV-2 assay for use on the Hologic Panther system and to increase manufacturing capacity for the Panther Fusion® SARS-CoV-2 assay.

Emergency Use Authorization

On May 14, 2020, FDA issued an Emergency Use Authorization (EUA) to allow Holologic, Inc.’s Aptima® SARS-CoV-2-assay to be used to detect nucleic acid from SARS-CoV-2. FDA reissued the EUA on October 5, 2020.

  • This page last reviewed: October 26, 2020