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 Issues Statement on Draft USPSTF Breast Cancer Screening Guidelines

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

Related Content

Illinois Governor Approves State Breast Density Reporting Bill Into Law
News | Breast Density | August 13, 2018
Illinois Gov. Bruce Rauner approved the Illinois Breast Density Reporting Law (Public Act 100-0749) on Aug. 10, 2018...
PET Tracer Identifies Estrogen Receptor Expression Differences in Breast Cancer Patients
News | PET Imaging | August 09, 2018
In metastatic breast cancer, prognosis and treatment is largely influenced by estrogen receptor (ER) expression of the...
iCAD Receives FDA Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis
Technology | Breast Density | August 08, 2018
iCAD announced U.S. Food and Drug Administration (FDA) clearance of its latest artificial intelligence (AI) software...
Cardiac Imaging Reveals Roots of Preeclampsia Damage in Pregnant Women
News | Women's Health | August 07, 2018
Johns Hopkins researchers say a heart imaging study of scores of pregnant women with the most severe and dangerous form...
Cardiac Monitoring a Higher Priority for High-Risk Breast Cancer Patients
News | Cardio-oncology | August 07, 2018
August 7, 2018 — While heart failure is an uncommon complication of...
Hologic Acquires Digital Specimen Radiography Company Faxitron Bioptics

VisionCT 3-D breast specimen-designated computed tomography (CT) system. Image courtesy of Faxitron Bioptics.

News | Breast Imaging | July 31, 2018
Hologic Inc. announced it has completed the acquisition of Faxitron Bioptics, a privately-held leader in digital...
Konica Minolta Hosting Lunch and Learn at 23rd Annual Mammography Meeting in Santa Fe
News | Breast Imaging | July 31, 2018
Konica Minolta Healthcare Americas Inc. will sponsor a lunch and learn featuring its Exa Mammo platform during the 23rd...
FDA Approves New Tomosynthesis Quality Control Tests for ACR Digital Mammography QC Manual
News | Mammography | July 30, 2018
The U.S. Food and Drug Administration (FDA) recently approved the American College of Radiology’s (ACR’s) amendment to...
The Magtrace and Sentimag Magnetic Localization System uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal. The FDA granted approval of the Sentimag System to Endomagnetics Inc.

The  Endomagnetics' Magtrace and Sentimag Magnetic Localization System uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal.

Technology | Women's Health | July 24, 2018
July 24, 2018 — The U.S.
Overlay Init