Hologic to Contribute to H5N1 Bird Flu Test Development via Agreement Issued by CDC
18 Dicembre 2024 - 2:08PM
Business Wire
Hologic, Inc. (Nasdaq: HOLX) today announced that it has entered
into an agreement with the Centers for Disease Control and
Prevention (CDC) to develop analyte specific reagents (ASRs) — the
“active ingredients” of laboratory-developed tests used to identify
specific diseases or conditions — that would aid in the detection
of H5N1 bird flu.
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Panther Fusion® system (Photo: Business
Wire)
H5N1 bird flu, also known as avian influenza A (H5N1), continues
to spread among wild birds worldwide and is causing outbreaks in
poultry and dairy cows in the U.S., with several recent cases
identified in humans who work with these animals.1 Illness from the
virus in the U.S. has been mild but severe illness in other
countries has been associated with this virus.2 To prepare for if
the current outbreak worsens, Hologic will work with the CDC to
develop reagents that may be used for H5N1 testing.
“During the COVID-19 pandemic, our teams pivoted rapidly and
rose to the challenge of developing critical tests to help curtail
the virus’s spread,” said Jennifer Schneiders, Ph.D., President,
Diagnostic Solutions. “Hologic’s proven expertise in assay
development, innovative instrumentation and extensive reach
uniquely position us well to proactively address ever evolving and
emerging public health threats.”
The contract will fund proof-of-concept development of ASRs —
primers and probes, in this case — that could eventually be
incorporated into laboratory-developed tests (LDTs) designed to
detect H5N1. While Hologic does not currently intend to make these
ASRs commercially available, the company may explore future
commercialization should the need for rapid implementation of H5N1
testing arise.
The ASRs are being developed on the Panther Fusion® system, a
fully automated molecular testing platform that allows labs to
quickly consolidate and run multiple assays for women's health,
infectious disease and SARS-CoV-2 (COVID-19) testing.
The high-throughput Panther® system has an extensive presence
throughout the laboratory community, with more than 1,700 systems
installed in public health laboratories, hospitals and private
reference laboratories across the U.S. Nearly 500 of the U.S.
Panther systems installed are Panther Fusion systems, which can
generate over 1,000 results in 24 hours and have the flexibility to
rapidly scale up testing capacity without the need for additional
instruments or operator training in the event of an outbreak or
pandemic.
Hologic’s Open Access® functionality on the Panther Fusion
system also allows labs to develop and automate their own LDTs
using a workflow that is easily integrated with U.S. Food and Drug
Administration (FDA)-approved in vitro diagnostic (IVD) assay
workflows on the system. This can help save time and labor compared
with more manual, low-throughput molecular testing workflows.
The development of these ASRs for detection of H5N1 bird flu
builds on Hologic’s existing strong portfolio of diagnostic
solutions, including assays used for detection of COVID-19. In
2020, Hologic rapidly developed the Panther Fusion® SARS-CoV-2
assay and the Aptima® SARS-CoV-2 assay. These tests played a
critical role in the global pandemic response, with more than 68
million shipped to 40 countries in 2020 alone. The company
continues to innovate in this area, most recently with FDA
clearance in 2023 of a test that can detect SARS-CoV-2, influenza A
and B, and RSV in a single patient sample.
For more information, please visit www.hologic.com.
About Hologic, Inc.
Hologic, Inc. is a global leader in women’s health dedicated to
developing innovative medical technologies that effectively detect,
diagnosis and treat health conditions and raise the standard of
care around the world. To learn more, visit www.hologic.com and
connect with us on LinkedIn, Facebook, X (Twitter), Instagram and
YouTube.
Forward-Looking Statements
This news release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic products. There can be no assurance 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, as the actual effect of the use of the products
can only be determined on a case-by-case basis. 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 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 data or
statements are based.
Hologic, The Science of Sure, Aptima, Open Access, Panther and
Panther Fusion are trademarks and/or registered trademarks of
Hologic, Inc. and/or its subsidiaries in the United States and/or
other countries.
References
1 Centers for Disease Control and Prevention. H5 Bird Flu:
Current Situation.
https://www.cdc.gov/bird-flu/situation-summary/index.html 2 Centers
for Disease Control and Prevention. What Causes Bird Flu Virus
Infections in Humans?
https://www.cdc.gov/bird-flu/virus-transmission/avian-in-humans.html
SOURCE: Hologic, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20241218942183/en/
Media Contact Bridget Perry Sr. Director, Corporate
Communications (+1) 508.263.8654 bridget.perry@hologic.com
Investor Contact Ryan Simon Vice President, Investor
Relations (+1) 858.410.8514 ryan.simon@hologic.com
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