MARLBOROUGH, Mass.,
June 7, 2017 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today that the
Genius™ 3D Mammography™ exam is now the
only mammogram that is FDA-approved as superior to standard 2D
mammography for routine breast cancer screening of women with dense
breasts.1
The Genius exam has been commercially available in the United States since 2011, and the newly
approved physician labeling is based on clinical studies proving
that the exam improves invasive breast cancer detection while
reducing unnecessary recalls among women of all breast densities,
including those with dense breasts.
Between 40 and 50 percent of women ages 40 to 74 have dense
breasts.2,3 Density is only identifiable on a mammogram
or other imaging modalities, and reflects how much fibrous or
glandular tissue is in the breast. Women with dense breasts often
require additional imaging, which can result in increased patient
anxiety and unnecessary costs. Perhaps most importantly, women with
very dense breasts are four to five times more likely to develop
breast cancer than women with less dense breasts.4,5 To
increase awareness of this issue, thirty-one states require some
level of breast density notification after a mammogram, but
often this can result in confusion for women receiving the
notification letters.
"Radiologists and referring physicians needed an answer for how
to screen the roughly half of women with dense breasts, because
until now, this patient population was confused and frustrated
without a clear path forward," said Pete
Valenti, Hologic's Division President, Breast and Skeletal
Health Solutions. "We are pleased today to provide this definitive
guidance from the FDA that the Genius exam is a superior screening
solution for women with dense breasts. This is yet another reason
referring physicians can feel confident in recommending Hologic's
Genius exam."
Separately, subgroup data analysis from a previously published
retrospective multicenter clinical study (JAMA 2014) supporting
breast tomosynthesis as the standard of care in women starting at
age 40 has recently been made available. This study, "Effect of age
on breast cancer screening using tomosynthesis in combination with
digital mammography," led by Elizabeth
Rafferty, MD, was published online in advance of print in
Breast Cancer Research and Treatment and analyzed the
performance of tomosynthesis in specific age groups. The study
showed that with the addition of tomosynthesis to digital
mammography, detection rates for invasive cancer increased
significantly for women ages 40 to 69.6 At the
same time, there was a significant decrease in recall rates for all
age groups, with the largest performance gains seen in women age 40
to 49.6
"Patients, and even referring physicians, have been confused
about the current recommendations on when to start screening for
breast cancer given the conflicting guidance from medical
societies," said Rafferty. "The fact that tomosynthesis offers
specific benefit to women in their 40s is not surprising, but the
magnitude of that benefit was unexpected. We needed a better
screening tool, and tomosynthesis fills that void. The substantial
increase in cancer detection, along with fewer false positive
studies, should address any concerns that have lingered over
screening this population of women. The time has come for
tomosynthesis to be viewed as the standard of care for breast
cancer screening, beginning at age 40."
The new density labeling is the latest notable claim for
Hologic's Genius exam, which is the only mammogram clinically
proven to detect 20 to 65 percent more invasive breast cancers
compared to 2D alone, with an average increase of 41
percent.7
"It is clear that all tomosynthesis is not the same," said
Valenti. "The key benefits of Hologic's Genius exam elevate it
above all other tomosynthesis offerings in the marketplace. The
Genius exam satisfies all the critical needs for breast cancer
screening, from improving invasive cancer detection to
significantly reducing recalls, and is designed to provide
meaningful improvements in patient satisfaction and reduced costs
to health systems."
The Genius 3D Mammography™ exam is only available on a Hologic®
3D Mammography™ system. It 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. There are more than 4,000 Hologic
3D Mammography™ systems in use in the U.S. alone so all women have
convenient access to the Genius exam. To learn more about the
Genius exam, visit http://www.mygenius3d.com/.
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.
Hologic, Dimensions, Genius, 3D, 3D Mammography, 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 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.
This information is not intended as a product solicitation or
promotion where such activities are prohibited. For specific
information on what products are available for sale in a particular
country, please contact a local Hologic sales representative or
write to womenshealth@hologic.com.
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
*Compared to standard 2D mammography alone.
1 U.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.
2 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.
3 Sprague BL, Gangnon RE, Burt V, et al. Prevalence of
mammographically dense breasts in the
United States. J Natl Cancer Inst. 106(10), 2014.
4 Boyd 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.
5 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. 103(15):1179-89, 2011.
6 Rafferty E, Rose S, Miller D, et al. Effect of age on
breast cancer screening using tomosynthesis in combination with
digital mammography. Breast Cancer Research and Treatment –
Clinical Trial – DOI 10.1007/s10549-017-4299-0.
7 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 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.
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SOURCE Hologic, Inc.