Proposed rule highlights the risks of breast density and emphasizes
important advances in mammography technology, including 3D mammography
MARLBOROUGH, Mass.--(BUSINESS WIRE)--
Hologic, Inc. (Nasdaq: HOLX), the world leader in breast cancer
screening technology and the company behind the Genius™ 3D Mammography™
exam, applauds the U.S. Food and Drug Administration’s proposed rule
updating its regulations issued under the Mammography
Quality Standards Act (MQSA) of 1992. The proposed amendments, the
first changes made to the act in 20 years, emphasize the significant
role breast density can play in cancer detection and require uniform
reporting of a patient’s breast density to patients and medical
providers nationwide.
“We commend the FDA for recognizing the significance of breast density
and wholeheartedly believe that arming women with this critical
knowledge is a major step forward for breast health,” said Pete Valenti,
Hologic’s Division President, Breast and Skeletal Health Solutions.
“Better informed patients make smarter decisions, like screening with
the Genius™ exam, the only mammography exam FDA approved to find more
cancers in dense breasts.”
Nearly half of women between the ages of 40 to 74 have dense breasts,
which can make it difficult to detect breast cancer during annual
screenings as the dense tissue can obscure cancers.1,2 Additionally,
women with very dense breasts are four to five times more likely to
develop breast cancer than women with less dense breasts.3,4
Hologic’s Genius™ exam provides radiologists with a series of images,
allowing them to evaluate the breast layer by layer and identify cancers
that may be hidden by breast tissue. The Genius™ exam is the only
mammography exam FDA approved to find more cancers and reduce recalls in
dense breasts.5
Today, more than 50 percent of mammography systems across the country
utilize breast tomosynthesis, according to MQSA data. Since 2011,
Hologic has installed more than 6,000 3D Mammography™ systems
throughout the United States. The Genius™ Mammography System is the only
mammography exam clinically proven to detect 20 to 65 percent more
invasive breast cancers compared to 2D alone, and is only available on a
Hologic® 3D Mammography™ system.6 To learn more
about the Genius™ exam, visit www.mygenius3d.com.
The Genius™ exam consists of a 2D and 3D™ image set, where the 2D image
can be either an acquired 2D image or a 2D image generated from the 3D™
image set.
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 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 or 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. 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 data or statements
are based.
Hologic, Genius, 3D, 3D Mammography, 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.
References
1 Ho JM, Jafferjee N, Covarrubias GM, Ghesani M, Handler B.
Dense breasts: a review of reporting legislation and available
supplemental screening options. AJR Am J Roentgenol. 203(2):449-56, 2014.
2
Sprague BL, Gangnon RE, Burt V, et al. Prevalence of mammographically
dense breasts in the United States. J Natl Cancer Inst. 106(10), 2014.
3Boyd
NF, Guo H, Martin LJ, et al. Mammographic density and the risk and
detection of breast cancer. N Engl J Med. 356(3):227-36, 2007.
4Yaghjyan
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. 103(15):1179-89, 2011.
5U.S.
Food & Drug Administration Premarket Approval (PMA). FDA.gov https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080003S005 accessed June
5, 2017.
6 Results from Friedewald, SM, et al. "Breast
cancer screening using tomosynthesis in combination with digital
mammography." JAMA 311.24 (2014): 2499-2507; a
multi-site (13), non-randomized, historical control study of 454,000
screening mammograms investigating the initial impact of the
introduction of the Hologic Selenia® Dimensions® system on screening
outcomes. Individual results may vary. The study found that 1.2 (95% CI:
0.8-1.6) additional invasive breast cancers per 1000 screening exams
were found in women receiving combined 2D FFDM and 3D™ mammograms
acquired with the Hologic® 3D Mammography™ System versus women receiving
2D FFDM mammograms only.
SOURCE: Hologic, Inc.
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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
Source: Hologic, Inc.