The newly approved labeling came based on clinical studies which reported that the exam improves invasive breast cancer detection while reducing unnecessary recalls for women with all breast densities. The Genius exam has been available in the US since 2011, the Marlborough, Mass.-based company said.
“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. 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. It is clear that all tomosynthesis is not the same. The key benefits of Hologic’s Genius exam elevate it above all other tomosynthesis offerings in the marketplace. The Genius exam satisfies all the critical needs for breast cancer screening, from improving invasive cancer detection to significantly reducing recalls, and is designed to provide meaningful improvements in patient satisfaction and reduced costs to health systems,” Hologic breast and skeletal health solutions prez Pete Valenti said in a press release.
Subgroup data analysis from a retrospective multicenter clinical study reported that breast tomosynthesis in combination with digital mammography improved detection rates significantly for women age 40 to 69, with a significant decrease in recall rates for all age groups.
“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. The fact that tomosynthesis offers specific benefit to women in their 40s is not surprising, but the magnitude of that benefit was unexpected. We needed a better screening tool, and tomosynthesis fills that void. The substantial increase in cancer detection, along with fewer false positive studies, should address any concerns that have lingered over screening this population of women. The time has come for tomosynthesis to be viewed as the standard of care for breast cancer screening, beginning at age 40,” study lead Dr. Elizabeth Rafferty said in a prepared statement.
Last month, Hologic saw shares dip despite the medical device maker posting 2nd quarter earnings that beat expectations on Wall Street.
The company posted profits of $526.8 million, or $1.84 per share on sales of $715.4 million for the 3 months ended April 1, for bottom-line growth of 664% while sales grew 3.2% compared with the same period last year.