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

Rhea-AI Summary

Hologic, Inc. (NASDAQ: HOLX) has expanded its Global Access Initiative (GAI) to include the Aptima® SARS-CoV-2 assay, aimed at improving access to COVID-19 diagnostics in resource-limited countries. The GAI, launched in 2018, facilitates affordable diagnostic testing without upfront costs. Hologic has already provided over 700,000 SARS-CoV-2 tests during the pandemic, partnered with organizations like WHO and UNICEF. This expansion enhances accessibility and reflects Hologic's commitment to equitable health systems worldwide.

Positive

• Inclusion of Aptima® SARS-CoV-2 assay in GAI enhances diagnostic access in underserved markets.
• Hologic has delivered over 700,000 COVID-19 tests, establishing strong market presence.

Negative

• No assurance on full market authorization for the Aptima® SARS-CoV-2 assay in all countries.
• Uncertainty regarding manufacturing capacity to meet potential demand.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220105005189/en/

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

Source: Hologic, Inc.

FAQ

What is the Aptima® SARS-CoV-2 assay launched by Hologic?

The Aptima® SARS-CoV-2 assay is a diagnostic test for COVID-19 that has been added to Hologic's Global Access Initiative.

How many COVID-19 tests has Hologic delivered to resource-limited countries?

Hologic has delivered over 700,000 COVID-19 tests to resource-limited countries throughout the pandemic.

What is Hologic's Global Access Initiative (GAI)?

The Global Access Initiative (GAI) is a program by Hologic designed to provide affordable diagnostic testing to resource-limited countries.

When was the Global Access Initiative launched?

The Global Access Initiative was launched in 2018 at the International AIDS Conference.

What partnerships does Hologic have for the GAI?

Hologic partners with organizations like WHO, UNICEF, and the Global Fund to facilitate access to diagnostic tests.