On Friday, the FDA approved Hologic's claim that Genius 3D mammography is superior to standard 2-D mammography for screening women with dense breasts.
The approval was based on clinical studies that demonstrated the Genius exam improves invasive breast cancer detection and reduces unnecessary recalls in women of all breast densities. It's now the only tomosynthesis solution on the market approved for that indication.
Around 43 percent of women between the ages 40 and 74 in the U.S. have dense breasts, according to a 2014 study published in the Journal of the National Cancer Institute.
Another study published in the same journal found that these women have a 3.39-fold increased risk of breast cancer compared to women with lower breast density.
A total of 31 states require some level of breast density notification after a mammogram, but there's confusion about what should be done after that. Pete Valenti, president of the breast and skeletal health solutions division at Hologic, believes that referring physicians can now be confident when recommending Hologic's Genius exam.
"Patients, and even referring physicians, have been confused about the current recommendations on when to start screening for breast cancer, given the conflicting guidance from medical societies," Dr. Elizabeth Rafferty of Lawrence General Hospital in Massachusetts, said in a statement.
"The time has come for tomosynthesis to be viewed as the standard of care for breast cancer screening, beginning at age 40," she added.
GE Healthcare's SenoClaire 3-D Breast Tomosynthesis received FDA approval in 2014. In May, it was announced that Siemens Healthineers' MAMMOMAT Inspiration and MAMMOMAT Inspiration PRIME edition digital mammography systems can be used as standalone 3-D mammography systems.
Hologic stated that the Genius exam is the only one clinically proven to detect between 20 and 65 percent more invasive breast cancers, compared to 2-D mammography alone.
The Genius exam is only available on a Hologic 3D Mammography system. It involves a 2-D and 3-D image set, in which the 2-D image can either be acquired alone or generated from the 3-D image set.
Currently, more than 4,000 Hologic Mammography systems are in use in the U.S.
