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Hologic Receives Emergency Use Authorization for Second SARS-CoV-2 Test

NEW YORK ─ Hologic said Friday it has received Emergency Use Authorization from the US Food and Drug Administration for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

The test runs on the firm's fully automated Panther system, more than 1,000 of which are installed in US clinical laboratories. Each Panther system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours, Hologic said. The Marlborough, Massachusetts-based medical technology company has begun distributing the coronavirus test and expects to produce an average of 1 million per week.

The Panther system is a fully automated, high-throughput molecular diagnostic platform that is widely used, with more than 1,800 systems installed in 60 countries. Approximately 750 US hospital, public health, and reference labs use the Panther system and its suite of Aptima assays to perform molecular tests for sexually transmitted infections, cervical cancer screening, and viral load monitoring in people with HIV and hepatitis.

Combining significant manufacturing capacity for the new test with its large installed base of high-throughput molecular instruments will dramatically increase testing capabilities, Hologic said.

"Delivering test results when and where they are needed, so people can either get back to work or quarantine themselves, is key to reopening global economies safely," Steve MacMillan, the company’s chairman, president, and CEO, said in a statement.

Certain aspects of the Aptima SARS-CoV-2 assay project were conducted under a $13 million award, announced in April, from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

Hologic said later this month it plans to register its Aptima SARS-CoV-2 assay for a CE mark for diagnostic use in Europe.

The company had announced in March that it received an EUA for its first SARS-CoV-2 assay, which runs on the Panther Fusion, a standalone system or module that can be attached to existing Panther systems in the field to extend testing capabilities.