Hologic Obtains European CE Mark for Use of Saliva Samples with COVID-19 Test

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In full transparency, the following press release was submitted to SOURCE media through its business wire service.

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MARLBOROUGH – Hologic, Inc.has obtained a CE Mark for the use of saliva samples with the Aptima® SARS-CoV-2 assay in Europe. The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19. The test runs on the fully automated Panther® system.

“This new CE Mark demonstrates our commitment to providing European consumers and healthcare providers as many options as possible to manage the ongoing pandemic,” said Jan Verstreken, Hologic’s group president, International. “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.”

Collection of saliva is easy, noninvasive and painless. The availability of this alternative specimen type should help facilitate screening in schools, workplaces and other settings. Certain European health authorities have determined that the established assay performance with saliva and the ease of obtaining the sample make saliva suitable for programs that use repeated screenings. The Aptima SARS-CoV-2 assay is also CE-marked for use with nasopharyngeal and nasal swabs as well as additional specimen types.

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. Approximately 2,600 Panther systems have been installed in clinical diagnostic laboratories around the world.

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Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. The company is located in Marlborough.

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