Hologic, Marlborough, Mass, is planning to launch a new Aptima molecular assay to detect the SARS-CoV-2 virus. The new test will run on the company’s Panther system.
The company expects to begin distributing a research use only version of its Aptima SARS-CoV-2 test to hospital, public health, and reference laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high-complexity tests. Labs may use the assay for clinical testing after completing performance verification testing.
Hologic plans to apply for FDA emergency use authorization for the Aptima SARS-CoV-2 test, and to register the test for a CE mark for diagnostic use in Europe.
“Our second COVID-19 test leverages the same proprietary Aptima chemistry and Panther instrumentation that have made Hologic a leader in molecular diagnostics for other infectious diseases,” says Steve MacMillan, chairman, president, and chief executive officer of Hologic. “The ability to deliver test results when and where they are needed—so people can either get back to work or quarantine themselves—has emerged as a key to reopening global economies. We are responding to this need by developing a second test that can be produced in much larger quantities than our first and run on a much larger installed base of instruments.”
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