Hologic gets CE Mark for COVID-19 test

2019 02 01 17 54 2200 Hologic Rsna 2018 400

Hologic announced it has received the CE Mark for the use of saliva samples with its Aptima SARS-CoV-2 assay in Europe. The assay also has the CE Mark for use with nasopharyngeal and nasal swabs as well as additional specimen types.

The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19 and runs on the fully automated Panther system, Hologic said.

The company said it has expanded manufacturing capability to produce Aptima tests in large quantities and has shipped more than 100 million Aptima COVID-19 tests globally since the spring of 2020. Approximately 2,600 Panther systems have been installed in clinical diagnostic laboratories around the world, Hologic added.

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