FDA Approves Hologic’s Genius 3D Mammography Exam

Hologic Inc. has announced that 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.

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 improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts.

Between 40 and 50 percent 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 imaging, 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, 31 states require some level of breast density notification after a mammogram, but often this can result in confusion for women receiving the notification letters.

“Radiologists and referring physicians needed an answer for how to screen the roughly half of women with dense breasts, because until now, this patient population was confused and frustrated without a clear path forward,” said Pete Valenti, Hologic’s division president, breast and skeletal health solutions. “We are pleased today to provide this definitive guidance from the FDA that the Genius exam is a superior screening solution for women with dense breasts. This is yet another reason referring physicians can feel confident in recommending Hologic’s Genius exam.”

The new density labeling is the latest notable claim for Hologic’s Genius exam, which is the only mammogram clinically proven to detect 20 to 65 percent more invasive breast cancers compared to 2D alone, with an average increase of 41 percent.

The Genius 3D Mammography exam is only available on a Hologic 3D Mammography system. It 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.

To learn more about the Genius exam, visit http://www.mygenius3d.com/.