Commercial Release of 3D (Breast Tomosynthesis) Biopsy Option Strengthens Hologic’s Position as Provider of the Nation’s Most Comprehensive Portfolio of Interventional Breast Health Solutions

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, recently expanded its extensive array of interventional and imaging solutions for breast health with the launch of the world’s first 3D breast biopsy option. This technology was developed for the Company’s Affirm upright breast biopsy guidance system, which is used in conjunction with the Selenia Dimensions 2D and 3D mammography systems. 

The Affirm 3D biopsy procedure is designed for the localization and accurate targeting of regions of interest and is especially important for targeting lesions not always detected in 2D images or when using other modalities. This new biopsy technique has numerous advantages over traditional stereotactic biopsy procedures, including faster lesion targeting and reduced patient procedure time. In addition, the Affirm system is pre-programmed for use with the Company’s Eviva and ATEC vacuum-assisted breast biopsy devices, providing easy integration of these best-in-class products.  

In June 2013, Magee-Womens Hospital of UPMC became the first facility in the nation to perform a tomosynthesis biopsy, a significant milestone for this new technology. Dr. Jules Sumkin, Chief of Radiology at Magee, performed the Affirm 3D biopsy procedure using the Eviva device. Additional information about this ground-breaking procedure can be found by following this link to the UPMC newsroom.  

“The Affirm 3D biopsy option is an important addition to our product portfolio,” says Dave Danielsen, Hologic’s Vice President and General Manager, Breast Imaging. “Physicians now have a new tool, tomosynthesis, to accurately identify regions of interest for biopsy. This addresses an emergent need users of our 3D mammography systems have identified – a biopsy technology that helps them locate lesions seen only on tomosynthesis images, as well as lesions that are better visualized using 3D imaging.”

The 3D biopsy option joins Hologic’s comprehensive suite of interventional breast health products, allowing users to depend on a single vendor for the majority of their breast health clinical needs. In addition to the Affirm upright biopsy system, the Company’s MultiCare Platinum biopsy table can be used to perform prone biopsy procedures. The versatile ATEC vacuum-assisted breast biopsy system can be used to perform biopsies under stereotactic, ultrasound, MRI or tomosynthesis guidance using the Company’s Eviva or ATEC devices. Hologic also provides a full line of biopsy site markers for use in all breast biopsy modalities.

Specimen radiography needs, whether in the operating room or imaging suite, can be met with Hologic’s Trident specimen radiography system. This system was developed in response to customer requests and utilizes Hologic’s flagship amorphous selenium, direct-capture detector, ensuring high-quality specimen imaging.