-

Hologic Adds Aptima SARS-CoV-2 Assay to its Global Access Initiative in Resource-Limited Countries

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (NASDAQ: HOLX) announces the addition of the Aptima® SARS-CoV-2 assay to its Global Access Initiative (GAI), a program designed to expand access to critical diagnostic testing in resource-limited countries.

As a global leader in diagnostics, Hologic launched the GAI at the 2018 International AIDS Conference with a breakthrough all-inclusive pricing structure with no upfront cost or capital expenditure. Qualified products included molecular assays for human immunodeficiency virus-1 (HIV-1), hepatitis B and C (HBV and HCV) and human papillomavirus (HPV), as well as the ThinPrep® Pap test for cervical cancer screening.

“Hologic remains committed to building diagnostic capacity and equitable health systems through affordable and accessible technical innovation,” said Joao Malagueira, Hologic’s vice president, EMEA Commercial. “We have a responsibility to bridge the diagnostic gap to sustainably control current and future disease outbreaks globally, and the expansion of the GAI to include our Aptima SARS-CoV-2 assay empowers countries to respond to the pandemic and control new waves of COVID-19.”

Throughout the pandemic, existing partnerships with the World Health Organization (WHO), UNICEF, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) assisted countries to quickly obtain SARS-CoV-2 tests at market pricing under existing procurement mechanisms. The Aptima SARS-CoV-2 assay is also available through the WHO Diagnostics Consortium, which secured critical volumes for countries with limited market access. To date, Hologic has delivered more than 700,000 tests for COVID-19 to resource-limited countries throughout the pandemic, in addition to routine supply of essential diagnostic tests for other viral infections to ensure continuity of care. Addition of the Aptima SARS-CoV-2 assay to the all-inclusive pricing structure of the GAI will enable further accessibility.

Interested customers should contact humancare@hologic.com to discuss pricing.

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. There can be no assurance the Aptima® SARS-CoV-2 assay will receive limited or full market authorization in each country included in the Global Access Initiative or achieve the benefits described herein. In addition, there can be no assurance that the assays 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, ThinPrep and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.

SOURCE: Hologic, Inc.

Contacts

Investor Contact
Ryan M. Simon
Vice President, Investor Relations
(858) 410-8514
ryan.simon@hologic.com

Media Contact
Jane Mazur
Vice President, Corporate Communications
(585) 355-5978
jane.mazur@hologic.com

Hologic, Inc.

NASDAQ:HOLX

Release Summary
Hologic Adds Aptima® SARS-CoV-2 Assay to its Global Access Initiative in Resource-Limited Countries
Release Versions

Contacts

Investor Contact
Ryan M. Simon
Vice President, Investor Relations
(858) 410-8514
ryan.simon@hologic.com

Media Contact
Jane Mazur
Vice President, Corporate Communications
(585) 355-5978
jane.mazur@hologic.com

More News From Hologic, Inc.

CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer...

Hologic’s New Sustainability Report Marks 40 Years of Impact

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc., a global leader in women’s health, today released its 2025 Sustainability Report. The new report coincides with Hologic’s 40th anniversary and underscores how the company’s longstanding purpose — to enable healthier lives for women everywhere, every day — continues to drive progress for patients, communities and the planet. “We have always firmly believed that our success as a company is fundamentally tied to our ability and commitment to help...

Hologic Secures Significant Patent Victory Against Siemens Over Breast Cancer Detection Technology

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. today announced a significant and far-reaching victory in the Unified Patent Court (UPC) in Germany, which ruled that Siemens* infringed upon a critical Hologic mammography technology patent in Siemens’ latest mammography system. The court imposed a sweeping injunction, immediately prohibiting Siemens from making, offering, placing on the market, using or importing or storing for those purposes its MAMMOMAT B.brilliant systems across Germany, F...
Back to Newsroom