Hologic, Inc. (Nasdaq: HOLX) announced today that its three SARS-CoV-2 tests all detect the recently emerged Omicron variant of the coronavirus that causes COVID-19. Initially identified in South Africa and subsequently in a number of African, European and North American countries, the Omicron variant (B.1.1.529) contains approximately 30 mutations.

Hologic conducted an analysis of genetic sequences from more than 175 Omicron-infected samples obtained through GISAID (Global Initiative On Sharing All Influenza Data, https://www.gisaid.org/) and determined that none of the new mutations occur within regions of the genome targeted by Hologic’s Aptima® SARS-CoV-2 Assay, Aptima® SARS-CoV-2/Flu Assay or Panther Fusion® SARS-CoV-2 Assay. Hologic has also received data from clinical users in Europe indicating that the Aptima SARS-CoV-2 assay detected Omicron COVID-19 infections in samples from inbound air travelers.

“We fully expect that SARS-CoV-2 will continue to evolve, as that is the natural path for viruses,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “We designed our assays with this in mind, and as a result, we are confident that the Omicron variant will not impact the performance of our assays.”

Aptima and Panther Fusion tests run on Hologic’s fully automated Panther® and Panther Fusion systems, respectively, which provide initial results in approximately three hours and can process more than 1,000 tests in 24 hours.

Hologic has provided more than 130 million SARS-CoV-2 assays to its laboratory customers, making a significant contribution to the global testing supply. More than 2,700 Panther systems are installed in clinical diagnostic laboratories around the world.

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.

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Aptima® SARS-CoV-2 Assay, Aptima® SARS-CoV-2/Flu Assay and Panther Fusion® SARS-CoV-2 Assay and the Panther® and Panther Fusion® systems. In addition, there can be no assurance that the products will be manufactured in adequate quantities to meet demand, 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, Aptima, Panther, Panther Fusion and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

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Hologic’s COVID-19 Tests Detect Omicron Variant