Hologic Applauds FDA’s Proposed Rule to Update Mammography Regulations Issued Under the Mammography Quality Standards Act (MQSA) of 1992
Hologic, Inc. (Nasdaq: HOLX), the world 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 Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “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 To learn more about the Genius exam, visit www.mygenius3d.com.
The Genius exam consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.