Hologic receives European approval for saliva COVID-19 test
PHOTO | Courtesy of Hologic
The Panther Fusion system from Hologic
Marlborough medical technology company Hologic said Wednesday it has been granted European approval for the use of saliva samples with its Aptima SARS-CoV-2 assay in Europe.
A press release announcing the CE Mark approval, as European health regulations are known, said the availability of this type of screening should help with testing in schools and workplaces as the collection of saliva is noninvasive and painless.
“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 of international, said in the release.
The Aptima SARS-CoV-2 test is a molecular diagnostic assay detecting the genetic material of the pathogen causing COVID-19 with the tests running on Hologic's Panther Fusion testing system.
Hologic 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, according to the release. Approximately 2,600 Panther systems have been installed in clinical diagnostic laboratories around the world.
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