BEDFORD, Mass., Feb. 10, 2014 /PRNewswire/ -- Hologic, Inc.
(Hologic or the Company) (NASDAQ: HOLX), a leading developer,
manufacturer and supplier of premium diagnostic products, medical
imaging systems and surgical products, with an emphasis on serving
the healthcare needs of women, announced today the publication of
three new studies supporting the use of Hologic's award-winning 3D
mammography (tomosynthesis) technology in breast cancer
screening.
A number of studies have validated the benefits of Hologic's 3D
mammography technology in screening: a simultaneous increase
in cancer detection rates, for invasive cancers in particular, and
a significant reduction in unnecessary patient recalls. Although
the benefits of 3D mammography far outweigh the perceived risks,
some potential users have expressed concern about the increased
dose of a combined conventional 2D and 3D mammography exam. While
the radiation dose from the combined 2D and 3D exposure is within
the U.S. guidelines for mammography, Hologic now offers customers
the low dose C-View software option which generates the 2D image
from the 3D mammography image slices thereby eliminating the need
for a separate 2D exposure.
Two studies published this month evaluated Hologic's Digital
Breast Tomosynthesis using 2D images generated from the 3D
mammography slices in place of conventional 2D images – a
technique that would reduce the radiation dose of 3D mammography
studies to the level of conventional 2D screening and shorten the
patient exam time while maintaining all the clinical benefits of
3D. A third study evaluated the use of one-view versus two-view
tomosynthesis.
Oslo Study. The results of a four-year prospective trial
based on 24,901 screening examinations in a large hospital in
Norway, "Two-View Digital Breast
Tomosynthesis Screening with Synthetically Reconstructed Projection
Images: Comparison with Digital Breast Tomosynthesis with
Full-Field Digital Mammographic Images," evaluated the use of 2D
images generated from the 3D mammography slices in place of
conventional 2D images that are required as part of the Digital
Breast Tomosynthesis procedure. Per Skaane, MD, PhD, Department of
Radiology, Oslo University Hospital
Ullevaal, and his colleagues found that the use of Hologic 3D and
generated 2D images constituted an average dose reduction of 45%
while not resulting in any clinically meaningful differences in
diagnostic accuracy compared to 3D mammography and conventional 2D
images. The study was published online in advance of print in the
January 24, 2014 issue of
Radiology, a scientific journal of the Radiological Society
of North America (RSNA).
UPMC Study. A reader study, "Comparison of
Two-dimensional Synthesized Mammograms versus Original Digital
Mammograms Alone in Combination with Tomosynthesis Images," also
looked at whether generated 2D images could be used in place of
conventional 2D images in a 3D mammography exam. The authors in
this retrospective study compared the results of eight expert
readers evaluating a set of cases representing the range of lesions
and normal confounders identified in clinical
practice. Margarita L. Zuley, MD, Department of Radiology,
Magee Women's Hospital, University of Pittsburgh Medical Center, and her
colleagues concluded that generated 2D images did not result in any
clinically meaningful differences in diagnostic accuracy and could
be used to eliminate the need for conventional 2D mammography as
part of a routine 3D mammography exam. The study was published
online in advance of print in the January
21, 2014 issue of Radiology.
Massachusetts General Hospital Study. A multi-reader
study, "Diagnostic Accuracy and Recall Rates for Digital
Mammography and Digital Mammography Combined with One-view and
Two-view Tomosynthesis: Results of an Enriched Reader Study," found
that while the addition of Hologic's one-view 3D mammography to
conventional digital mammography significantly improved diagnostic
accuracy and reduced the recall rate, the addition of Hologic's
two-view 3D mammography provided twice the performance gain in
diagnostic accuracy while further reducing unnecessary patient
recalls. The researchers concluded that "an approach combining
two-view 3D mammography with digital mammography should be the
model adopted in clinical practice." In addition, the researchers
showed that the addition of two-view 3D mammography provided
significantly higher diagnostic accuracy for imaging women with
dense breast tissue compared to conventional mammography.
Elizabeth A. Rafferty, MD,
Department of Radiology, Massachusetts General Hospital,
Harvard Medical School, was lead author
of this study that was published in the February 2014 issue of the American Journal of
Roentgenology (AJR), the scientific journal of the American
Roentgen Ray Society.
"Millions of women across the world have already benefited from
Hologic's 3D mammography technology," notes David Harding, Group Senior Vice President and
General Manager, Women's Health for Hologic. "These three new
studies add to the growing body of research supporting the
direction we have taken with this game-changing technology."
"We are glad to see support for our lower dose 3D mammography
offering," Harding said. "These studies have demonstrated that
Hologic's 3D mammography using generated 2D images results in a
clinically superior exam with virtually the same radiation dose as
a conventional 2D screening exam. And the research by Dr.
Rafferty and her colleagues is the latest in a string of studies
concluding that the use of two-views in a 3D mammography screening
exam should continue to be the model physicians use in clinical
practice."
Hologic pioneered the 3D mammography imaging market with the
introduction of its Selenia Dimensions 3D system in countries
recognizing the CE mark in 2008 and has placed 3D mammography
systems in 59 countries. In 2011 Hologic became the first, and
still today the only company to have a U.S. Food and Drug
Administration approved 3D mammography system.
About Hologic, Inc.:
Hologic, Inc. is a leading developer, manufacturer and supplier
of premium diagnostic products, medical imaging systems and
surgical products. The Company operates four core business units
focused on breast health, diagnostics, GYN surgical, and skeletal
health. With a comprehensive suite of technologies and a robust
research and development program, Hologic is committed to improving
lives. The Company is headquartered in Massachusetts. For more information, visit
www.hologic.com.
Hologic, C-View, Dimensions and Selenia are trademarks and/or
registered trademarks of Hologic, Inc., and/or its subsidiaries in
the United States and/or other
countries.
Forward-Looking Statement Disclaimer:
This News Release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic products. There can be no assurance these products
will achieve the benefits described herein and that such benefits
will be replicated in any particular manner with respect to an
individual patient as 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. 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 data or statements
are based.
Contacts:
Marianne
McMorrow
|
Jim Culley
|
Global PR &
Advertising Publicist
|
Senior Director,
Corporate Marketing
|
Hologic,
Inc.
|
Hologic,
Inc.
|
marianne.mcmorrow@hologic.com
|
jim.culley@hologic.com
|
Tel:
781.999.7723
|
Tel:
781.999.7583
|
SOURCE Hologic, Inc.