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yrus Diagnostic Imaging is proud to serve our patients with the latest 3D Mammography Screening using Hologic’s breast tomosynthesis technology.
FDA Approves Hologic’s Genius™ 3D Mammography™ Exam as the Only Mammogram Superior for Women with Dense Breasts
The U.S. Food and Drug Administration (FDA) has approved expanded physician labeling for Hologic’s Genius™ 3D Mammography™ exam available on a Hologic 3D Mammography™ system.
With this new indication, 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.i
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 significantly improves invasive breast cancer detection compared to 2D alone. In addition, the Genius exam also has been proven to reduce unnecessary recalls among women of all ages and breast densities.
Between 40% and 50% of women ages 40 to 74 have dense breasts. 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 screening, 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. To increase awareness of this issue, thirty one states require some level of breast density notification after a mammogram. However, this often can result in confusion for women receiving the notification letters if there is no additional explanation.
“The benefits of Hologic’s Genius 3D™ exams elevate it above all other tomosynthesis systems,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “A Genius exam satisfies the critical needs of breast cancer screening for women starting at age 40 and for women of all breast density types. Hologic’s Genius exams are designed to provide superior breast imaging versus conventional 2D exams, meaningful improvements in patient satisfaction, and reduced costs to the healthcare system.”
Hologic’s expanded physician labeling is based on clinical studies proving that exams using Hologic’s 3D™ systems improve invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts.
Original Research: Hologic 3D Mammography™ as a Function of Age
Effect of Age on Breast Cancer Screening Using Genius™ 3D Mammography™ in Combination with Digital Mammography
Single center and multicenter studies have demonstrated that the addition of Hologic 3D Mammography™ (breast tomosynthesis) to digital mammography increases detection of invasive cancers while simultaneously lowering recall rates from screening in the general population. However, data regarding the potential benefits of 3D Mammography™ for specific patient subgroups have been limited.
A retrospective study by Dr. Elizabeth Rafferty and investigators from 13 U.S. Hologic 3D mammography™ sites was published online in advance of print on May 18th in Breast Cancer Research and Treatment.iv The researchers evaluated the differential performance of digital mammography combined with 3D mammography™ compared to digital mammography alone as a function of age in a screening population. A total of 452,320 examinations (278,906 digital mammograms compared to 173,414 3D™ mammograms) were analyzed.
The researchers found that for women 40-49, 50-59, and 60-69 years of age, the addition of 3D mammography™ to digital mammography was associated with both an increased cancer detection rate and decreased recall rate; moreover, the increased incremental performance seen was independent of, and not accounted for, by breast density.
The addition of 3D Mammography™ to digital mammography significantly reduced the recall rate for ALL age groups.
The addition of 3D Mammography™ to digital mammography significantly reduced the recall rate for ALL age groups.
The magnitude of performance gains was greatest for women aged 40-49 and argues strongly for tomosynthesis screening for breast cancer detection as the standard of care for women beginning at the age of 40.
In 2016, Dr. Rafferty and a multi site team of investigators examined the benefits of 3D Mammography™ in women with both dense and nondense breasts using the same population of over 450,000 patient exams. Their results, published in The Journal of the American Medical Association (JAMA), found that the Hologic 3D Mammography™ exam is a better screening option for women of all breast densities compared to digital mammography alone.
The age and density studies brought together most of the same principal investigators from the groundbreaking 2014 study on 3D Mammography™ exams published in JAMA. The 2014 study has been viewed over 50,000 times on the JAMA web site. Over 150 research papers have cited the original work.
The benefits of 3D Mammography™ could lower the costs associated with needless follow-up exams, and improve patient experience for women seeking a more accurate screening mammogram.