Study using Hologic 3D Mammography systems is the largest to date
involving 139 doctors from 13 U.S. academic and community-based sites
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.
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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. 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 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
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
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.
 Friedewald SM, Rafferty EA, Rose SL, Durand MA, Plecha DM, Greenberg
JS, Hayes MK, Copit DS, Carlson KL, Cink TM, Barke LD, Greer LN, Miller
DP, Conant EF. Breast Cancer Screening Using Tomosynthesis in
Combination with Digital Mammography. JAMA. June 25, 2014
SOURCE: Hologic, Inc.
For further information:
Deborah R. Gordon
Vice President, Investor Relations and Corporate Communications
Senior Director, Investor Relations
Senior Director, Corporate Communications
Manager, Corporate Communications