Hologic (NSDQ:HOLX) announced today that it received FDA emergency use authorization (EUA) for its Aptima SARS-CoV-2 assay for detecting COVID-19.
Marlborough, Mass.-based Hologic’s Aptima test runs on its fully automated Panther system that provides initial results in approximately three hours, processing more than 1,000 coronavirus tests in 24 hours.
Hologic said in a news release that it began distributing the new test and expects to produce an average of one million tests per week by combining its manufacturing capacity with what it touts as the world’s largest installed base of high-throughput molecular instruments.
Aspects of the Aptima assay project were conducted under a $13 million contract from the U.S. Dept. of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA).
Hologic intends to register the Aptima SARS-CoV-2 assay for CE Mark approval in Europe later this month, according to the release. The company landed EUA for its first COVID-19 diagnostic in March.
“Delivering test results when and where they are needed – so people can either get back to work or quarantine themselves – is key to re-opening global economies safely,” Hologic chairman, president & CEO Steve MacMillan said in the release. “I’m so proud of the incredible teamwork across the company that brought this test to market so quickly.”