Hologic Announces Contract with BARDA to Support IVD Approval of COVID Assays
November 02 2022 - 8:02AM
Business Wire
Agency Awards $19 Million Contract to Fund
Research and Development
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.
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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
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