Hologic Announces Two New Respiratory Assays for the Detection of COVID-19, Flu A, Flu B and RSV
11 July 2022 - 10:00PM
Business Wire
--New assays for the Panther Fusion and
Novodiag Systems further build on Hologic’s leading molecular
scalable solutions offering to European customers--
Hologic, Inc. (Nasdaq: HOLX) announced today that it is now
offering its Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay and its
Novodiag® RESP-4 molecular diagnostic test for sale in the European
Union in time for the northern hemisphere’s respiratory viral
season. Both assays detect and differentiate four of the most
prevalent respiratory viruses that can present with 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).
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a
high-performance cartridge-based assay that runs on the fully
automated high-throughput Panther Fusion system. The test uses
nasopharyngeal swab samples.
The Novodiag RESP-4 assay runs on the Novodiag system, the fully
automated molecular diagnostic solution that delivers on-demand
testing for infectious disease and antimicrobial resistance. This
test also uses nasopharyngeal swab samples and includes an embedded
cellularity control to ensure that the sample was correctly
taken.
Both products are compliant with the European In Vitro
Diagnostic Medical Device Directive (IVDD) 98/79/EC, and transition
provisions for such devices included in the IVD Regulation (EU)
2017/746.
“As we move into the next phase of COVID, it is important that
we evolve our assays to support our customers with tests that
enable them to differentiate between the multiple respiratory
pathogens as easily as possible. The ability to accurately
differentiate between respiratory viruses with similar symptoms is
essential if physicians are to ensure optimized care for each
patient,” said Jan Verstreken, Group President International.
“Together, these two assays further build our international
offering of molecular diagnostic scalable solutions that meet the
growing needs of a broad range of customers, from single-patient
rapid testing to population-level screening.”
He continued, “The RESP-4 assay, developed and manufactured in
Espoo, Finland is the first new Novodiag assay to be launched since
Hologic’s acquisition of Mobidiag in June 2021. The Panther Fusion
SARS-CoV-2/Flu A/B/RSV assay was developed and will be manufactured
at our facility in San Diego, CA. It adds to our quickly growing
menu of Panther Fusion assays, including the Panther Fusion EBV and
BKV assays designed and manufactured at our recently acquired
facility in Liège, Belgium.”
The launch of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
adds to the respiratory portfolio for the Panther Fusion system,
which currently includes the Panther Fusion Flu A/B/RSV assay, the
Panther Fusion Paraflu (Parainfluenza 1/2/3/4) assay, the Panther
Fusion AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus)
and the Panther Fusion Bordetella assay.
The launch of the Novodiag RESP-4 assay further expands the
Novodiag assay menu, which currently includes diagnostic assays for
gastrointestinal infections, hospital acquired infections,
antimicrobial resistance and respiratory infections.
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 AccessTM functionality to run laboratory
developed tests.
About the Novodiag System
The Novodiag system combines real-time PCR and microarray
capabilities that enable multiple pathogens to be identified in a
single sample, providing a simple and fast way to pinpoint patients
most at risk with targeted and syndromic on-demand testing. It
delivers clinically relevant results in central labs or tertiary
settings and its rapid ‘sample-in, result-out’ system allows for
the fully automated detection of novel coronavirus in approximately
one hour. It can be used as the main molecular platform for
emergency, decentralised, and out-of-hours testing, or in
association with the Panther® System.
About Hologic, Inc.
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 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.
Hologic, The Science of Sure, Mobidiag, Novodiag, Panther,
Panther Fusion and associated logos are trademarks and/or
registered trademarks of Hologic, Inc. 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/20220711005201/en/
Investor Contact: Ryan Simon +1 858.410.8514
ryan.simon@hologic.com
Media Contact: Jane Mazur +1 508.263.8764
jane.mazur@hologic.com
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