Hologic Announces Contract with BARDA to Support IVD Approval of COVID Assays

Rhea-AI Summary

Hologic, Inc. (NASDAQ: HOLX) has secured a $19 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to enhance its SARS-CoV-2 diagnostics. This funding aims to align Hologic's Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay and Aptima® SARS-CoV-2 assay with FDA in vitro diagnostic standards. The Panther Fusion assay, currently under U.S. development after receiving CE-marking in May 2022, will further clinical efforts for nasal sample claims and market authorization for asymptomatic COVID-19 testing.

Positive

• Awarded $19 million contract from BARDA for diagnostic development.
• Funding supports transition of COVID testing from EUA to full market authorization.
• Panther Fusion® assay received CE-marking in May 2022 for EU market.

Negative

• None.

Agency Awards $19 Million Contract to Fund Research and Development

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc. (Nasdaq: HOLX) announced today that it has been awarded a $19 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to support research and development efforts. This funding will help to bring Hologic’s Panther Fusion^® SARS-CoV-2/Flu A/B/RSV assay and Aptima^® SARS-CoV-2 assay in line with the U.S. Food and Drug Administration’s (FDA) in vitro diagnostic (IVD) standards.

Hologic’s Aptima^® SARS-CoV-2 assay received Emergency Use Authorization (EUA) from the FDA in May 2020. The Panther Fusion^® SARS-CoV-2/Flu A/B/RSV assay is currently under development in the United States, while having achieved CE-marking in May 2022 to allow commercialization in the European Union. The Panther Fusion^® SARS-CoV-2/Flu A/B/RSV assay is a real-time PCR test, while the Aptima® SARS-CoV-2 assay utilizes Hologic’s proprietary TMA^® technology. These tests run on Hologic’s fully automated Panther Fusion^® and Panther^® systems, respectively.

This BARDA contract will support clinical efforts to obtain claims for nasal samples using the Panther Fusion, as well as full market authorization for COVID-19 testing of asymptomatic individuals who have reason to be tested.

“Hologic has made a significant impact responding to the pandemic by providing millions of highly accurate molecular tests,” said Kevin Thornal, Group President, Global Diagnostic Solutions at Hologic. “With the help of our tremendous partners at BARDA, and as the pandemic moves to its next phase, we look forward to transitioning COVID testing from EUA to full market authorization, as well as improving the country’s readiness for future pandemics.”

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50122C00057.

For more information, visit www.hologic.com.

About the Panther and Panther Fusion Systems

The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory-developed tests.

About Hologic, Inc.

Hologic, Inc. is a global medical technology innovator primarily focused on improving women’s health and well-being through early detection and treatment. Its advancements include invention of the world’s first commercial 3D mammography system to fight breast cancer; leadership in testing for cervical cancer, sexually transmitted infections, respiratory illnesses, and the virus that causes COVID-19; and minimally invasive surgical technologies for uterine fibroids and abnormal uterine bleeding.

The company also champions women through the Hologic Global Women’s Health Index, which provides a science-backed data roadmap for improving women’s well-being, and Project Health Equality, which elevates awareness, research insights and access to quality care for underserved women.

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

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 that 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 publicly release 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.

This information is not intended as a product solicitation or promotion where such activities are prohibited. For specific information on what products are available for sale in a particular country, please contact a local Hologic sales representative or write to womenshealth@hologic.com.

Source: Hologic, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221102005207/en/

Investor Contact:

Ryan Simon

Vice President, Investor Relations

858.410.8514

ryan.simon@hologic.com

Media Contact:

Jane Mazur

Vice President, Corporate Communications

508.263.8764

jane.mazur@hologic.com

Source: Hologic, Inc.

FAQ

What is the recent contract awarded to Hologic (HOLX) about?

Hologic was awarded a $19 million contract from BARDA to enhance its SARS-CoV-2 diagnostics.

How will the BARDA contract impact Hologic's COVID-19 testing capabilities?

The contract will support clinical efforts to obtain market authorization for the Panther Fusion® diagnostic test.

Has Hologic's Panther Fusion® SARS-CoV-2 assay received any certifications?

Yes, it received CE-marking in May 2022, allowing commercialization in the European Union.

What technologies do Hologic's SARS-CoV-2 assays utilize?

The Panther Fusion® assay uses real-time PCR, and the Aptima® assay employs Hologic's proprietary TMA® technology.

When did Hologic's Aptima® SARS-CoV-2 assay receive Emergency Use Authorization?

The Aptima® SARS-CoV-2 assay received Emergency Use Authorization from the FDA in May 2020.