BEDFORD, Mass., June 25, 2014 /CNW/ -- Hologic, Inc.
(NASDAQ: HOLX) today announced that a groundbreaking study
published in the June 25, 2014 issue of the Journal of the
American Medical Association (JAMA), found that Hologic's 3D
Mammography (breast tomosynthesis) screening technology finds
significantly more invasive cancers than a traditional mammogram.
The researchers also found that 3D mammography reduces the number
of women called back for unnecessary testing due to false alarms.
That reduces anxiety, as well as health care costs.
To view the multimedia assets associated with this release,
please click:
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The study, "Breast Cancer Screening Using Tomosynthesis in
Combination with Digital Mammography," was led by Sarah M. Friedewald, MD of the Caldwell Breast
Center, Advocate Lutheran General Hospital in Park Ridge, Illinois.[1] A total of 454,850
examinations (281,187 conventional mammograms compared to 173,663
3D mammography exams) were included in the study.
Significant findings include:
- A 41% increase in the detection of invasive breast cancers.
(p<.001)
- A 29% increase in the detection of all breast cancers.
(p<.001)
- A 15% decrease in women recalled for additional imaging.
(p<.001)
- A 49% increase in Positive Predictive Value (PPV) for a recall.
(p<.001)
PPV for recall is a widely used measure of the proportion of
women recalled from screening that are found to have breast cancer.
The PPV for a recall increased from 4.3 to 6.4%.
- A 21% increase in PPV for biopsy. (p<.001)
PPV for biopsy is a widely used measure of the proportion of
women having a breast biopsy that are found to have breast cancer.
The PPV for a breast biopsy increased from 24.2 to 29.2%.
- No significant change in the detection of ductal carcinoma in
situ (DCIS).
DCIS is a non-invasive cancer. It has not spread beyond the milk
duct into any normal surrounding breast tissue.
"The JAMA 3D study validates the findings of previously
published studies but on a much larger scale," said Peter J. Valenti III, Hologic Division
President, Breast and Skeletal Health Solutions. "The study
addresses the two most frequently cited concerns with breast cancer
screening – that we are finding too many cancers that don't need to
be treated and that too many women are being called back for
unnecessary additional testing. Each of the outcomes measured was
statistically significant and reinforced the benefits of Hologic 3D
Mammography in addressing these challenges."
Five leading academic hospitals participated in the study:
Massachusetts General Hospital; Yale
University School of Medicine in Connecticut; University Hospitals Case Medical
Center in Ohio; Albert Einstein
Healthcare Network, and the Perelman School of Medicine of the
University of Pennsylvania in
Pennsylvania.
Eight community-based sites participated in the study: Caldwell
Breast Center of Advocate Lutheran General Hospital in Illinois; TOPS Comprehensive Breast Center in
Texas; Washington Radiology
Associates, PC in Washington, DC;
Radiology Associates of Hollywood
and Memorial Healthcare System in Florida; Evergreen Health Breast Center and
Radia Inc, PS in the state of Washington; Edith Sanford Breast Health
Institute in South Dakota;
Invision Sally Jobe Breast Centers and Radiology Imaging Associates
in Colorado; and John C. Lincoln
Breast Health and Research Center in Arizona.
About Hologic 3D Mammography:
While digital (2D) mammography is considered one of the most
advanced breast cancer screening technologies available today, it
provides only a two-dimensional picture of the breast. The breast
is a three-dimensional object composed of different structures,
such as blood vessels, milk ducts, fat, and ligaments. These
structures, which are located at different heights within the
breast, can overlap and cause confusion when viewed as a
two-dimensional, flat image. This confusion of overlapping tissue
is a leading reason why small breast cancers may be missed and
normal tissue may appear abnormal, leading to unnecessary call
backs.
Hologic 3D Mammography is the first and currently the only FDA
approved 3D mammography system in the U.S. It has been shown in
numerous clinical studies to significantly increase the detection
of invasive breast cancers while simultaneously reducing recall
rates across all patient populations and breast densities. This
technology was approved for breast cancer screening and diagnosis
in the U.S. in February, 2011 and has been available in countries
recognizing the CE mark since 2008. Hologic's 3D mammography
technology is in use in all 50 states and over 50 countries.
An estimated 6 million women in the U.S. will be screened with
the technology in 2014. Hologic has over 1,100 3D mammography
systems installed in the U.S. A Hologic 3D Mammography site finder
is available at www.3Dmammography.com.
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.
Forward-looking Statement Disclaimer:
This News Release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic's 3D Mammography (breast tomosynthesis) technology.
There can be no assurance this product 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:
Investor
Deborah R.
Gordon
Vice President,
Investor Relations and Corporate Communications
(781)
999-7716
deborah.gordon@hologic.com
Al Kildani
Senior Director,
Investor Relations
(858)
410-8653
al.kildani@hologic.com
|
Media
Jim Culley
Senior Director,
Corporate Communications
(781)
999-7583
jim.culley@hologic.com
Marianne
McMorrow
Manager, Corporate
Communications
(781)
999-7723
marianne.mcmorrow@hologic.com
|
Copyright 2014 Canada NewsWire
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