Proposed rule highlights the risks of breast density, emphasizes important advances in mammography technology
Hologic Inc., a leader in breast cancer screening technology and the company behind the Genius 3D Mammography exam, applauds the U.S. Food and Drug Administration’s proposed rule updating its regulations issued under the Mammography Quality Standards Act (MQSA) of 1992. The proposed amendments, the first changes made to the act in 20 years, emphasize the significant role breast density can play in cancer detection and require uniform reporting of a patient’s breast density to patients and medical providers nationwide.
“We commend the FDA for recognizing the significance of breast density and wholeheartedly believe that arming women with this critical knowledge is a major step forward for breast health,” said Hologic’s Pete Valenti. “Better informed patients make smarter decisions, like screening with the Genius exam, the only mammography exam FDA approved to find more cancers in dense breasts.”
Nearly half of women between the ages of 40 to 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings as the dense tissue can obscure cancers.1,2 Additionally, women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts.3,4 Hologic’s Genius exam provides radiologists with a series of images, allowing them to evaluate the breast layer by layer and identify cancers that may be hidden by breast tissue. The Genius exam is the only mammography exam FDA approved to find more cancers and reduce recalls in dense breasts.5
Today, more than 50 percent of mammography systems across the country utilize breast tomosynthesis, according to MQSA data. Since 2011, Hologic has installed more than 6,000 3D Mammography systems throughout the United States. The Genius Mammography System is the only mammography exam clinically proven to detect 20 to 65 percent more invasive breast cancers compared to 2D alone, and is only available on a Hologic 3D Mammography system.6
For more information, visit www.mygenius3d.com.
References
1. 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.
2. Sprague BL, Gangnon RE, Burt V, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 106(10), 2014.
3. 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.
4. 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.
5. 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.
6. Results from Friedewald, SM, et al. “Breast cancer screening using tomosynthesis in combination with digital mammography.” JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact of the introduction of the Hologic Selenia® Dimensions® system on screening outcomes. Individual results may vary. The study found that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2D FFDM and 3D™ mammograms acquired with the Hologic® 3D Mammography™ System versus women receiving 2D FFDM mammograms only.
