Hologic Genius 3D Tomosynthesis Mammography System FDA Approved for Better Visualization of Dense Breasts

Hologic received FDA approval to offer its Genius 3D Mammography system as superior to traditional 2D mammography for screening of women with dense breasts. Though Genius 3D has been available in the U.S. since 2011, recently performed clinical studies have demonstrated that “the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts,” according to Hologic.

Women with dense breasts tend to develop breast cancer more frequently, yet it is dense breasts that are difficult to analyze using mammography. Repeat exams are often required, which bring with them extra radiation exposure and additional costs, yet there has not been clear indication from the FDA that there are better options for such women. This is the first such approval from the FDA.

From Hologic:

…subgroup data analysis from a previously published retrospective multicenter clinical study (JAMA 2014) supporting breast tomosynthesis as the standard of care in women starting at age 40 has recently been made available. This study, “Effect of age on breast cancer screening using tomosynthesis in combination with digital mammography,” led by Elizabeth Rafferty, MD, was published online in advance of print in Breast Cancer Research and Treatment and analyzed the performance of tomosynthesis in specific age groups. The study showed that with the addition of tomosynthesis to digital mammography, detection rates for invasive cancer increased significantly for women ages 40 to 69.  At the same time, there was a significant decrease in recall rates for all age groups, with the largest performance gains seen in women age 40 to 49.

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.

Info page: Genius 3D Mammography…

Via: Hologic…