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Hologic Issues Statement on Draft USPSTF Breast Cancer Screening Guidelines

-- By Focusing on Older Data, Government Task Force Underestimates

the Benefits that Newer Technologies Like Breast Tomosynthesis Offer Women --

BEDFORD, Mass., April 22, 2015 -- Hologic, Inc. issued the following statement today on the draft 2015 guidelines for breast cancer screening published this week by the U.S. Preventive Services Task Force (USPSTF).

Hologic is committed to helping women live longer, stronger, healthier lives.  As a leader in the breast health field, we stand for better certainty for all women in the early detection of cancer.  We are pleased that the government-sponsored advisory panel recognized that lives are saved by breast cancer screening beginning at the age of 40.  On the other hand, we are disappointed in the Task Force’s proposed guidelines on when women should be screened and how often, and their conclusion that current evidence is insufficient to assess the benefits of breast tomosynthesis (3D mammography exams).

The USPSTF’s draft guidelines can be found here.1

We have two main concerns with the proposed guidelines.

First, Hologic believes that women 40 and up benefit from mammography.  The American Cancer Society (ACS) estimates that approximately 65,000 new female breast cancer cases (about 50,000 invasive) are diagnosed each year in women under 50.  Furthermore, the ACS estimates that close to 4,000 women between the ages of 40 and 49 die annually from breast cancer.2

According to Susan G. Komen President and CEO Judith A. Salerno, M.D., M.S, the proposed Task Force guidelines are “especially troublesome for younger women (who are often diagnosed with aggressive forms of breast cancer), and for African American women who are often diagnosed with aggressive forms of the disease at younger ages than white women.”3

Hologic supports access to mammography for women 40 to 49 years old, including an annual exam when a woman and her doctor agree this is appropriate.  We note that the American Cancer Society, the American Congress of Obstetricians and Gynecologists, the American College of Radiologyand the American Medical Associationhave also taken the position that mammograms should begin at age 40 and be done annually.

Hologic’s second concern with the proposed guidelines is that the Task Force gives too much weight to studies conducted when film-screen mammography was the industry standard, while dismissing the benefits of newer and clinically proven technologies like Hologic’s 3D mammography exams.

“The Task Force was selective in what they considered, and discounted the extensive clinical evidence in support of the benefits of Hologic 3D mammography exams,” said Pete Valenti, Hologic Division President, Breast and Skeletal Health Solutions. “By reducing the number of women called back for unnecessary additional testing and simultaneously detecting more invasive cancers earlier, Hologic 3D mammography systems clearly address the limitations of traditional 2D mammography.”

More than 100 published, peer-reviewed research studies have examined the clinical benefits of Hologic 3D mammography, including a groundbreaking study involving nearly 500,000 exams. The study, "Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography," published in the Journal of the American Medical Association (JAMA), found that Hologic 3D mammography exams detect 41% more invasive cancers than traditional 2D mammography exams, while reducing by 15% the number of women called back for unnecessary testing due to false positives.4

“Traditional film and digital systems are not as effective as 3D mammography in clearly identifying early stage cancers, and thus lead to more false positives,” said radiologist Linda Greer, MD, Medical Director of the HonorHealth Breast Health and Research Center in Phoenix and a co-author of the JAMA study.  “Because the USPSTF largely based their draft recommendation on film and digital outcomes, their recommendations are as outdated as the technologies themselves.  After four years of working with Hologic’s 3D mammography system, I believe it is the most significant advance in breast cancer screening that I have seen in my career.”

The proposed USPSTF guidelines are a draft open for public comment.  We urge the Task Force to support regular screening for women ages 40 to 49, and reconsider the extensive body of clinical evidence on the benefits and safety of Hologic 3D mammography exams.

Hologic welcomes comments on this position statement and other women's health issues.  Please contact the Company at womenshealth@hologic.com.

About Hologic 3D Mammography Exams

Traditional digital mammography 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.

Genius 3D mammography is available on the Hologic Selenia Dimensions 3D system.  Hologic’s 3D mammography was the first exam to be found clinically superior to 2D mammography by the FDA.  Hologic 3D mammography systems have been in clinical use in breast cancer screening for eight years, and systems are now in use in all 50 states and more than 50 countries of the world.  A Hologic 3D mammography system site finder is available at www.3Dmammography.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.

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about Hologic 3D mammography and approaches to breast cancer screening.  There can be no assurance this system or approaches will achieve the benefits described herein 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 system and different breast cancer screening approaches 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 statements are based.

Hologic, 3D mammography, Dimensions, 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.

 

Contacts

Investors

Michael Watts

Vice President, Investor Relations and Corporate Communications

(858) 410-8588

 

Media

Jim Culley

Senior Director, Corporate Communications

(781) 999-7583

Cell: (302) 528-1312

 


[2] American Cancer Society, Breast Cancer Facts and Figures, 2013-2014.

[3] http://komencolumbus.org/susan-g-komen-statement-on-u-s-preventative-services-task-force-mammography-screening-guidelines/

[4] Friedewald SM, Rafferty EA, Rose SL, Durand MA, Plecha DM, Greenberg JS, Hayes MK, Copit DS, Carlson KLCink TM, Barke LD, Greer LN, Miller DP, Conant EF.  Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography. JAMA. June 25, 2014