Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
19 Maio 2023 - 9:08AM
Business Wire
Multiplexed Respiratory Test Now Available in
the U.S. With New RespDirect Collection Kit
Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food
and Drug Administration (FDA) has granted 510(k) clearance for the
company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This assay
is a molecular diagnostic test that detects and differentiates four
of the most prevalent respiratory viruses that can exhibit similar
clinical symptoms: severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2), influenza A (flu A), influenza B (flu B) and
respiratory syncytial virus (RSV).
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Panther Fusion® SARS-CoV-2/Flu A/B/RSV
assay (Photo: Business Wire)
“This past winter, we saw several respiratory illnesses — COVID,
flu and RSV — spreading simultaneously throughout communities and
often presenting with similar symptoms, making diagnoses
difficult,” said Hologic Diagnostic Solutions President Jennifer
Schneiders, Ph.D. “While we are out of the respiratory virus season
this year, accurate viral diagnosis remains a high priority for
clinicians for the upcoming respiratory season and we are committed
to advancing COVID and respiratory diagnostics on our Panther
Fusion system. This test will be a critical tool to help determine
which respiratory virus or coinfection patients have so that
providers can better inform the best course of treatment.”
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on the
fully automated, high-throughput Panther Fusion system, which
provides initial results in approximately three hours and can
process more than 1,000 tests in 24 hours. The flexible approach of
this system, along with Hologic’s respiratory virus menu, offers
various testing options from a single sample and allows healthcare
professionals and laboratories to personalize patient testing based
on medical history and local prevalence.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay launches with
the new RespDirect™ collection kit, which enables laboratories to
directly load samples for processing on the Panther Fusion system
without any uncapping or specimen transfer steps, saving time and
reducing the potential for error, repetitive stress injuries and
exposure to viruses.
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 number
75A50121P00022.
Since the beginning of the COVID pandemic, Hologic has shipped
more than 200 million SARS-CoV-2 laboratory diagnostic tests
worldwide. FDA clearance of the Panther Fusion SARS-CoV-2/Flu
A/B/RSV assay follows the July 2022 announcement of CE marking for
the same test in Europe, furthering Hologic’s position as one of
the world’s largest molecular diagnostic companies.
About the Panther and Panther Fusion Systems
The Panther system is a best-in-class, fully automated,
sample-to-result molecular diagnostics 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,
respiratory infection, viral load, transplant viruses and other
infectious disease testing, which can all be done simultaneously.
The Panther Fusion module, which is an addition to the Panther
system, provides an expanded and growing in vitro diagnostics menu,
as well as Open Access™ functionality to run laboratory-developed
tests. Learn more about Panther Fusion Respiratory Assays.
About Hologic
Hologic Inc. is a global medical technology innovator focused on
improving the health and well-being of women, their families and
communities 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 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.
Hologic, Open Access, Panther, Panther Fusion, RespDirect and
The Science of Sure are trademarks and/or registered trademarks of
Hologic Inc. and/or its subsidiaries in the United States and/or
other countries.
Source: Hologic Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20230519005034/en/
Media Contact: Bridget Perry 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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