MARLBOROUGH, Mass.,
Oct. 26, 2017 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today that it has
received 510(k) clearance from the United States Food and Drug
Administration (FDA) for its Panther Fusion® Paraflu assay, a
multiplexed assay which runs on the new Panther Fusion®
system.
The Fusion Paraflu assay detects and differentiates
Parainfluenza viruses 1, 2, 3, and 4. It is the second
diagnostic assay available on the Panther Fusion system,
complementing the Panther Fusion Flu A/B/RSV assay, which received
clearance several weeks ago.
Human parainfluenza viruses (HPIVs) commonly cause respiratory
illnesses in infants and young children. Most patients recover, but
HPIVs can also cause more severe conditions, including croup and
pneumonia. Four types of HPIVs circulate at different times of the
year.1
"It's important to identify the cause of any infection to make
sound clinical decisions about treatment," said Tom West, president of the Diagnostic Solutions
Division at Hologic. "Molecular diagnostic tests have become the
gold standard for pathogen detection due to their sensitivity and
specificity."
In addition to the Panther Fusion Paraflu and Flu A/B/RSV
assays, a third multiplexed assay, the Panther Fusion AdV/hMPV/RV
(adenovirus/human metapneumovirus/rhinovirus) assay, is under
review by the FDA. This assay is not currently available for
sale in the United States.
Once all three Panther Fusion assays are cleared, they will
offer a modular approach to syndromic respiratory testing via the
ability to run one, two or all three assays from a single patient
specimen. The Panther Fusion assays also utilize ready-to-use
reagents, which offer up to 60-day on-board stability.
"Our modular approach will enable laboratories to conduct
respiratory testing in an efficient and cost-effective manner,"
said West. "The availability of three panels focused on the most
frequently ordered tests allows labs the flexibility to meet
specific patient needs without running unnecessary tests."
The Panther Fusion is available as a full system, or the Panther
Fusion module can be attached to existing Panther systems in the
field to extend testing capabilities. Specifically, the Panther
Fusion module adds the capacity to run PCR (polymerase chain
reaction) assays in addition to tests based on TMA
(transcription-mediated amplification), the proprietary Hologic
chemistry that powers the Company's Aptima® brand. The
Panther Fusion system retains all the key benefits of the Panther
platform, including full sample-to-result automation, the ability
to run multiple tests from a single sample, random and continuous
access, sample processing with rapid turnaround time, continuous
loading, and STAT capabilities.
The Panther Fusion system and Panther Fusion Flu A/B/RSV,
Paraflu, and AdV/hMPV/RV assays have been CE-marked for diagnostic
use and are commercially available in Europe.
About Hologic
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
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
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
statements are based.
Hologic, Panther, Panther Fusion, Aptima and The Science of Sure
are trademarks and/or registered trademarks of Hologic, Inc. in
the United States and/or other
countries.
Investor Contact:
Michael
Watts
+1 858.410.8588
michael.watts@hologic.com
Media Contact:
Jane
Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
jane.mazur@hologic.com
References
1. https://www.cdc.gov/parainfluenza/index.html. Accessed
October 20, 2017.
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SOURCE Hologic, Inc.