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Hologic Obtains CE Mark for Use of Saliva With SARS-CoV-2 Molecular Test

NEW YORK ─ Hologic said on Wednesday that it has obtained CE marking for the use of saliva samples with its Aptima SARS-CoV-2 molecular assay in Europe.

The availability of saliva should help facilitate screening in schools, workplaces, and other settings, Hologic noted.

Some European health authorities have decided that the performance of its assay with saliva and ease of obtaining saliva make the sample type suitable for repeated screenings, the firm said.

"While vaccination is helping stem the tide of COVID-19, we envision that testing will continue to play an important role, particularly in screening programs needed to reopen society," Jan Verstreken, Hologic’s group president, international, said in a statement.

The Aptima SARS-CoV-2 assay, which runs on the firm's fully automated Panther system, is also CE-marked for use with nasopharyngeal swabs, nasal swabs, and other types of samples.

In May 2020, Hologic received Emergency Use Authorization from the US Food and Drug Administration for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

The Marlborough, Massachusetts-based 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 last spring.