News | April 22, 2015

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

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 Radiology and the American Medical Association have 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 percent 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, M.D., 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.  

For more information: www.hologic.com

1.     http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementDraft/breast-cancer-screening1

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 KL, Cink TM, Barke LD, Greer LN, Miller DP, Conant EF. Breast Cancer Screening Using Tomosynthesis in Combination with Digital Mammography. JAMA. June 25, 2014

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