MARLBOROUGH, Mass.,
Dec. 6, 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® AdV/hMPV/RV assay, a
multiplexed assay that runs on the new Panther Fusion®
system.
The new assay detects Adenovirus, human Metapneumovirus, and
Rhinovirus. It is the third diagnostic assay available on the
Panther Fusion system, complementing the Panther Fusion Flu A/B/RSV
assay and the Panther Fusion Paraflu assay, which both received
clearance in October 2017.
"Clearance and launch of the new Fusion AdV/hMPV/RV assay
completes our initial set of modular assays for respiratory
viruses," said Tom West, president
of the Diagnostic Solutions division at Hologic. "We now offer a
suite of molecular assays that help labs maximize their efficiency
when running respiratory tests, in addition to the benefits of
doing so on the fully automated Panther Fusion system."
A number of respiratory panels currently on the market require
testing for 20 or more targets even when a physician has only
requested three or four, making testing time-consuming and
expensive for laboratories. The Panther Fusion assays 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 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.
Adenoviruses cause respiratory illnesses ranging from the common
cold to pneumonia, croup, and bronchitis, and also can cause
illnesses such as gastroenteritis, conjunctivitis, cystitis, and
neurological disease.1 Infants and people with
weakened immune systems are at high risk for developing severe
illnesses caused by Adenovirus infection.1 hMPV is
a common respiratory pathogen, particularly in infants and young
children. The virus is associated with both upper and lower
respiratory tract infections and may be a trigger for
asthma.2 Clinical symptoms of hMPV infection may
progress to bronchiolitis or pneumonia. Rhinoviruses are the
causative pathogens in more than half of viral respiratory
infections, and they are associated with acute exacerbations of
respiratory disease, including asthma, sinusitis, otitis media, and
COPD.3 A number of studies have confirmed rhinoviruses
as being the most common cause of "the common
cold."4
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
- https://www.cdc.gov/adenovirus/hcp/clinical-overview.html.
Accessed December 1, 2017.
- Kahn, J.S., Epidemiology of human metapneumovirus. Clin
Microbiol Rev, 2006. 19(3): p. 546-57.
- Anzueto, A. and M.S. Niederman. 2003. Diagnosis and treatment
of rhinovirus respiratory infections. Chest 123:1664-1672.
- Park, J. Y., Yun, K. W., Lim, J. W., Lee, M. K., Lim, I. S.,
and Choi, E. S. (2016) Clinical and genetic features of human
metapneumovirus infection in children. Pediatrics International,
58: 22–26. doi: 10.1111/ped.12782.
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SOURCE Hologic, Inc.