MARLBOROUGH, Mass.,
April 26, 2016 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced that study results
published today in a research letter in JAMA conclude that
breast tomosynthesis (Hologic's Genius™ 3D MAMMOGRAPHY™) exams
reduce recall rates, and increase invasive cancer detection in
women with both dense and nondense breasts. These key benefits of
3D MAMMOGRAPHY™ could lower the costs associated with needless
follow-up exams, and improve patient experience for women seeking a
more accurate screening mammogram.
Density is only identifiable on a mammogram or other imaging
system, and is a reflection of how much fibrous or glandular tissue
is in the breast. Higher breast density may increase a woman's
chance of getting breast cancer, make detection of cancer on
conventional mammography more difficult, and increase the chances
that a woman will be recalled for additional imaging.1,2
Mammograms are categorized into four density groups: almost
entirely fat, scattered fibroglandular densities, heterogeneously
dense, and extremely dense. The latter two groups are considered
dense; however, the vast majority of women whose mammograms are
considered dense have heterogeneously dense breast tissue.
"Density creates challenges for conventional mammography by
obscuring the images, which often results in additional visits and
exams for women," said Edward
Evantash, MD, board certified OB/GYN and Medical Director
for Hologic. "This new analysis confirms that Genius™ 3D
MAMMOGRAPHY™ exams reduce unnecessary follow-up exams in
dense-breasted women. This has the potential to provide health
systems and insurance companies with significant cost savings,
reduce patient stress and expenses, and alleviate challenges for
referring physicians who are tasked with relaying mammography
results to their patients."
Improvements in both recall rate reduction and invasive cancer
detection were greatest for women with heterogeneously dense
breasts, with a 50 percent increase in invasive cancer detection
and a simultaneous 14 percent reduction in recall rate. Women with
heterogeneously dense breasts make up about 40 percent of the U.S.
screening population (women ages 40-74) — approximately 25 million
women in the U.S.
"Utilizing Genius™ 3D MAMMOGRAPHY™ exams for breast cancer
screening will reduce the need for subsequent unnecessary testing,
and decrease the number of unnecessary breast biopsies— addressing
concerns that were previously raised as limitations of conventional
mammography while also reducing costs for health systems," said
Pete Valenti, Hologic's Division
President, Breast and Skeletal Health Solutions. "Twenty-six states
have passed legislation requiring doctors to notify women if they
have dense breasts — and now these women who were previously
confused about how to proceed with breast cancer screening can feel
confident turning to 3D MAMMOGRAPHY™ exams to reduce their chances
of stressful recalls and help find more invasive cancer."
This study brought together the principal investigators from the
groundbreaking 2014 study on 3D MAMMOGRAPHY™ exams, also published
in JAMA, this time led by Elizabeth
Rafferty, MD, a co-author on the prior study.3 A
total of 452,320 examinations (278,906 conventional mammograms
compared to 173,414 Genius™ 3D MAMMOGRAPHY™ exams), were
analyzed.
Genius™ 3D MAMMOGRAPHY™ exams have been available in the U.S.
since 2011, and are only available on the Hologic Selenia®
Dimensions® mammography system. In 2015 an estimated 10 million
women in the U.S. benefited from a Genius™ exam. Additional
information, as well as a locator to find imaging sites offering
the exams, can be found at http://mygenius3d.com.
About Hologic
Hologic, Inc. is a leading developer,
manufacturer and supplier of premium diagnostic products, medical
imaging systems and surgical products. The Company's core business
units focus on diagnostics, breast health, GYN surgical and
skeletal health. With a unified suite of technologies and a robust
research and development program, Hologic is dedicated to The
Science of Sure. For more information on Hologic, visit
www.hologic.com.
Hologic, 3D, 3D Mammography, Dimensions, Genius, Selenia, and
the Science of Sure are trademarks and/or registered trademarks of
Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.
Forward-Looking Statements
This news release may
contain forward-looking information that involves risks and
uncertainties, including statements about the use of Hologic
mammography systems. There can be no assurance the systems will
achieve the benefits described here, 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 systems 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 the systems will achieve any expected level of sales
or market share. Hologic expressly disclaims any obligation to
release publicly any updates to the data or statements presented
here to reflect any change in the Company's expectations or any
change in events, conditions or circumstances on which any such
data or statements are based.
Media Contact:
Jane
Mazur
508.263.8764 (direct)
585.355.5978 (mobile)
jane.mazur@hologic.com
Investor Contact:
Michael
Watts
858.410.8588
michael.watts@hologic.com
1 Yaghjyan L, Colditz GA, Collins LC, et al.
Mammographic breast density and subsequent risk of breast cancer in
postmenopausal women according to tumor characteristics. J Natl
Cancer Inst. 2011;103(15):1179-1189
2 Bertrand KA, Tamimi RM, Scott CG, et al. Mammographic
density and risk of breast cancer by age and tumor characteristics.
Breast Cancer Res. 2013;15(6):R104.
3 Friedewald SM, Rafferty EA, Rose SL, et al. Breast
cancer screening using tomosynthesis in combination with digital
mammography. JAMA. 2014;311(24):2499-2507.
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SOURCE Hologic, Inc.