MARLBOROUGH, Mass.,
Oct. 5, 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® Flu A/B/RSV assay
running on the new Panther Fusion® system.
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 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.
"Consolidating testing remains a key focus of our clinical
laboratory customers," said Tom
West, president of the Diagnostic Solutions Division at
Hologic. "Offering multiple chemistries on
a single platform expands menu while allowing labs to further
consolidate testing and meet efficiency goals."
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 access
sample processing, continuous loading, and STAT capabilities.
Additional benefits include a higher throughput of up to 335
Panther Fusion tests in eight hours, or up to 500 Fusion and Aptima
tests.
In addition to the current clearance of the Panther Fusion® Flu
A/B/RSV assay, two additional respiratory panels, the Panther
Fusion Paraflu assay and the Panther Fusion AdV/hMPV/RV
(adenovirus/human metapneumovirus/rhinovirus) assay, are under
review by the FDA. These assays are not currently available
for sale in the United States.
Once all three Panther Fusion respiratory assays are cleared,
they will offer a modular approach to 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.
"We have heard from customers that many panels currently on the
market are too large, requiring them to run up to 20 or more
targets when perhaps a physician has only requested three or four,"
said West. "Not only is this time-consuming for the lab, it is also
not cost-effective. By offering three smaller panels focused on the
tests most frequently requested, we will offer labs maximum
flexibility to design test runs to meet specific needs."
"Hologic has long-standing expertise in flu extending back to
the introduction of ProFlu+, the first FDA-cleared Flu A/B/RSV
assay on the market in 2008," said West. "This expertise has
translated to the development of a test with excellent performance,
and that test is now available on our integrated platform, which
fully automates all aspects of testing, from sample to result."
The Panther Fusion system substantially reduces hands-on time
for laboratories by providing random and continuous access with
rapid turnaround time. The new Panther Fusion PCR-based assays,
combined with select Aptima TMA assays, make the Panther Fusion
system the only instrument worldwide that combines TMA, real-time
TMA, and real-time PCR with full sample-to-result automation.
The Panther Fusion system and Panther Fusion Flu A/B/RSV,
Paraflu, and AdV/hMPV/RV assays have also 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
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SOURCE Hologic, Inc.