Hologic gets FDA approvable letter for breast tomo

Hologic is on the brink of realizing its ambition to pioneer the commercial use of 3D mammography in the U.S. The company, which for 25 years has focused on women's health, announced this morning receipt of an approvable letter from the FDA for its Selenia Dimensions digital mammography tomosynthesis system.

All that remains before this system can be marketed in the U.S. is a positive review and inspection by the FDA of the manufacturing facility, methods, and controls that Hologic has put in place to make the tomosynthesis product. The firm plans to schedule this inspection in the coming weeks. After that, it's up to the FDA.

"We are a conservative company and we're not giving any guidance on when we will be commercial (in the U.S.)," said James D. Culley, Ph.D., Hologic's director of marketing. "But I will say Hologic is fortunate to be in a position where we are ahead of everybody else in getting this technology to this point in development."

Hologic has pursued tomosynthesis as a commercial modality for the last five years, recruiting luminaries with track records in tomo going back a decade or more. With the culmination of their combined efforts almost within reach, Hologic is ideally positioned to lead a revolutionary change in breast cancer diagnosis in the U.S. This process has already begun.

Selenia Dimensions systems, built to do tomosynthesis, have been rolling off the company's production line for more than two years. Hundreds have landed in Europe, Canada, and Mexico. A few have found homes in the U.S., but only as 2D digital mammography systems. Converting them to 3D requires nothing more than a simple software upgrade, accomplished remotely, which Hologic will be more than happy to provide as soon as the FDA says it can do so. And that's just the beginning.

"There is a lot we can do beyond just tomosynthesis," Culley said. "We need to do CAD (computer-assisted detection) with tomo. We need to do contrast imaging and breast biopsy with tomo. These are actually being done in clinical environments in other countries and we are excited (at the prospect) of being able to move forward with this platform in the U.S."