FDA Oks Hologic's Genius 3D Mammography Exam As Superior To 2D Mammography

(RTTNews) - Hologic, Inc. (HOLX) said 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.2,3 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.

Separately, 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, 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 69.6 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 49.6.