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

Hologic, Inc. (Nasdaq: HOLX) 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.

For more information on the Aptima assays, visit www.hologic.com.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, The Science of Sure, Aptima, and Panther are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

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