MARLBOROUGH, Mass.,
Nov. 24, 2017 /PRNewswire/ --
Hologic, Inc. (Nasdaq: HOLX) announced today that it has received
510(k) clearance from the United States Food and Drug
Administration (FDA) for its Quantra™ 2.2 Breast
Density Assessment Software, which enables clinicians to provide
women with consistent breast density assessments during routine
breast cancer screenings.
The software is one of several groundbreaking products that will
be available for demonstration in Hologic's booth (#4705) at the
103rd Scientific Assembly and Annual Meeting of the
Radiological Society of North
America (RSNA) at McCormick Place in Chicago from Nov. 26 to
30.
Through a proprietary algorithm powered by machine learning,
Quantra software analyzes mammography images for distribution and
texture of breast tissue, delivering clinicians patient-specific
breast density assessment. Quantra software categorizes breasts
into four categories of density, in alignment with the ACR
BI-RADS® Atlas 5th
Edition.1,2
Nearly half of women between the ages of 40 and 74 have dense
breasts, which can make it difficult to detect breast cancer during
annual screenings and lead to additional imaging, resulting in
increased patient anxiety and unnecessary facility
costs.3,4 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.5,6 Breast density is only
identifiable on a mammogram or other screening modality, and has
historically been determined by the radiologist who reads the
image. With Quantra software, clinicians can feel confident they
are providing their patients with an unbiased breast density
assessment that removes the potential for visual subjectivity.
"As the global leader in breast cancer screening technology, we
relentlessly pursue the development of clinically superior products
that address the unmet and changing needs of our customers and
their patients, especially when it comes to breast density," said
Pete Valenti, Hologic's Division
President, Breast and Skeletal Health Solutions. "Quantra software
is yet another example of our dedication and we are proud to
feature it – along with a number of other new, breakthrough
products – for the world's leading radiologists at RSNA this
week."
Earlier this year, Hologic's Genius™ 3D
Mammography™ exam became the only mammogram approved
by the FDA as superior to standard 2D mammography for routine
breast cancer screening for women with dense
breasts.7 The updated labeling was based on
clinical studies proving that the exam improves invasive breast
cancer detection while reducing unnecessary recalls among women of
all breast densities. The expanded labeling provides clarity
for physicians who previously were unsure how to screen patients
with dense breasts.
Quantra software is available for use with Hologic®
3D Mammography™ systems, including the new
3Dimensions™ mammography system, which is designed to
be the fastest, highest resolution breast tomosynthesis system
ever, with the Intelligent™ 2D imaging
technology.8,9 On display at RSNA for the first time,
the 3Dimensions system offers a variety of features designed to
provide higher quality 3D™ images for radiologists,
enhanced workflow for technologists, and a more comfortable
mammography experience, with low-dose options, for
patients.9
In addition to the 3Dimensions system, RSNA attendees can
experience Hologic's comprehensive portfolio of breast and skeletal
health products designed to deliver improved patient satisfaction,
better clinician workflow and facility cost savings. They can also
visit Hologic's "New Product Theater," where representatives from
the Company's screening, interventional and skeletal teams will
present every hour during exhibition times. Presentations will
feature new products including the 3Dimensions system,
Brevera® breast biopsy system with
CorLumina® imaging technology, and
Fluoroscan® InSight™ FD Mini C-Arm
extremities imaging system, all of which will be showcased on the
exhibit floor.
Throughout the show, Hologic will host a number of interactive
workshops and educational symposia, two of which will address the
impact that breast tomosynthesis and breast density assessment
software can have on clinicians and women with dense breasts.
Additional workshops will focus on topics including
contrast-enhanced 2D mammography, advancements in 3D™
Mammography, and 3D™ image-guided biopsy solutions.
For more information or to RSVP, please visit HologicRSNA.com or
stop by Hologic's Booth #4705.
RSNA is an international society of radiologists, medical
physicists and other medical professionals with 55,000 members from
more than 140 countries. The RSNA Annual Meeting is expected to
attract more than 60,000 attendees.
The Genius™ 3D Mammography™ exam (also known as the
Genius™ 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 women have convenient access to the Genius exam. To
learn more about the Genius exam, visit
http://www.Genius3DNearMe.com.
The Quantra™ software requires the
Hologic® Cenova Server and minimal technical specs.
Hologic Cenova and Quantra™ products are only
available on Hologic® mammography systems.
About Hologic, Inc.
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, 3D, 3D Mammography, 3Dimensions, Brevera, CorLumina,
Fluoroscan, Genius, InSight and Quantra 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
_______________________________
1 FDA 510(k) K163623
2 Understanding Quantra™ (Version 2.2)
User Manual
3 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.
4 Sprague BL, Gangnon RE, Burt V, et al. Prevalence
of mammographically dense breasts in the
United States. J Natl Cancer Inst. 106(10), 2014.
5 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.
6 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.
7 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.
8 Data on file
9 Upon FDA approval and/or commercial
availability.
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SOURCE Hologic, Inc.