Hologic receives EUA for Covid-19 assay

15 May 2020 (Last Updated May 15th, 2020 15:38)

Hologic has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its Aptima SARS-CoV-2 assay.

The antigen test runs on Hologic’s fully automated Panther system, which can provide initial results within three hours and carry out over 1,000 Covid-19 tests within a 24-hour period.

The test was the first Covid-19 diagnostic to receive R&D support from the US government Biomedical Advanced Research and Development Authority (BARDA), receiving nearly $700,000 in funding.

Hologic plans to register its Aptima SARS-CoV-2 assay for a CE Mark for diagnostic use in Europe later in May.