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Hologic is set to launch a new Aptima molecular assay that will run on the Panther system for the detection of SARS-CoV-2 virus, which causes Covid-19.
The Panther system is a fully automated, high-throughput molecular diagnostic platform installed in 60 countries and 50 states in the US.
It can deliver initial results in three hours and can process over 1,000 coronavirus tests a day.
Hologic aims to scale up the testing capabilities in the US by combining its manufacturing capacity for the new test with its existing high-throughput molecular instruments across the country.
It will begin distributing a research use only (RUO) version of the test to the hospitals next week. The test will also be available to reference laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity tests.
Hologic chairman, president and CEO Steve MacMillan said: “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.”
The company said that it will approach the US Food and Drug Administration (FDA) next week for the emergency use authorisation (EUA) of Aptima SARS-CoV-2 assay.
Hologic also plans to register a CE Mark for diagnostic use in Europe next month.
Initially, Hologic will provide three million RUO Covid-19 detection tests to its laboratory customers in the US. The company aims to manufacture an average of at least one million Aptima SARS-CoV-2 assays a week from next month. It plans to scale up the production further in the coming months.
In March, Hologic received EUA for its first Covid-19 test, the Panther Fusion SARS-CoV-2 assay.