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Hologic Awarded $13M from BARDA to Develop Second Coronavirus Assay

NEW YORK ─ The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) said on Friday it has awarded $13 million to Hologic for the development of its Aptima SARS-CoV-2 assay.

Marlborough, Massachusetts-based Hologic is developing the assay for use on its Panther System, a fully automated high-throughput molecular diagnostic platform with more than 1,000 instruments installed in the US. Each Panther System can provide initial results in less than three hours and process more than 1,000 coronavirus tests in 24 hours, BARDA said.

Hologic announced last week its plans to launch the Aptima molecular assay, its second assay developed to detect the SARS-CoV-2 virus.

This week, Hologic expects to apply for FDA Emergency Use Authorization for the Aptima SARS-CoV-2 assay. The firm said it anticipates applying later in May for a CE mark for diagnostic use of the assay in Europe.

Starting in late May, Hologic expects to begin producing at least 1 million Aptima SARS-CoV-2 assays per week, BARDA noted.

BARDA said it had also supported the development of Hologic's first SARS-CoV-2 assay, which runs on the firm's Panther Fusion system and has been granted Emergency Use Authorization by the US Food and Drug Administration.