November 2, 2017 — Hologic Inc. announced that it will provide all mammography systems for the Dutch Breast Cancer Screening Program in partnership with Tromp Medical, Hologic’s distributor in the Netherlands. Under the tender, Hologic’s new 3Dimensions mammography systems will be installed in mobile and stationary screening facilities across the country, starting in 2018.
The multi-year agreement is the result of a comprehensive public procurement process conducted by Facilitaire Samenwerking Bevolkingsonderzoeken (FSB) on behalf of the five regional screening organizations responsible for nationwide breast screening in the Netherlands. The Dutch Breast Cancer Screening Program provides women between 50 and 75-years-old with a mammogram once every two years. Through the program, approximately 1.3 million women in the Netherlands are invited for screening each year.
FSB, on behalf of the five regional screening organizations, launched this public procurement process in 2016. A special prioritization was placed on finding new digital mammography systems that would improve the ergonomics of the screening experience for clinicians and the participating women. In addition to extensive testing among clinicians, a group of 30 participants in the screening program underwent tests on the equipment of all bidders. Both clinicians and participants ranked the 3Dimensions system No. 1 in ergonomics and patient comfort.
In Europe, the 3Dimensions system is available in both 3-D and 2-D configurations. The 2-D system is upgradeable to Hologic’s 3Dimensions, which detects up to 65 percent more invasive breast cancers and is the only mammogram approved by the U.S. Food and Drug Administration (FDA) as superior for women with dense breasts compared to 2D alone.[i],[ii]. It features Clarity HD high-resolution 3-D imaging, which provides the industry’s fastest, highest resolution 3-D images to accelerate screening and analysis, according to the company. The system is designed to clearly reveal subtle lesions and fine calcifications to help pinpoint cancers early. Designed to increase clinical confidence and achieve more accuracy the first time, Clarity HD reduces recalls by up to 40 percent compared to 2D alone.[iii],[iv],[v],[vi] In addition, the 3Dimensions system offers Intelligent 2-D imaging technology, which works with Clarity HD technology to deliver high clarity, contrast and detail at a lower dose, and the Quantra 2.2 breast density assessment software, which enables standardization in patient protocols, providing reproducible and consistent breast density assessment.
For more information: www.hologic.com
[i] Results from Friedewald, SM, et al. “Breast cancer screening using tomosynthesis in combination with digital mammography.” JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia® Dimensions® on screening outcomes. Individual results may vary. The study found an average 41% increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1,000 screening exams were found in women receiving combined 2D FFDM and 3D™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only.
[ii] FDA submissions P080003, P080003/S001, P080003/S004, P080003/S005.
[iii] Zuckerman SP, Conant EF, Keller BM, et al. Implementation of Synthesized Two-dimensional Mammography in a Population-based Digital Breast Tomosynthesis Screening Program. Radiology. 2016 Dec;281(3):730- 736.
[iv] Skaane P, Bandos A, Eben EB, et al. Two-view digital breast tomosynthesis screening with synthetically reconstructed projection images: comparison with digital breast tomosynthesis with full-field digital mammographic images. Radiology. 2014 Jun;271(3):655-63.
[v] Bernardi D, Macaskill P, Pellegrini M, et. al. Breast cancer screening with tomosynthesis (3D mammography) with acquired or synthetic 2D mammography compared with 2D mammography alone (STORM-2): a population-based prospective study. Lancet Oncol. 2016 Aug;17(8):1105-13.
[vi] McDonald ES, Oustimov A, Weinstein SP, et al. Effectiveness of Digital Breast Tomosynthesis Compared With Digital Mammography: Outcomes Analysis From 3 Years of Breast Cancer Screening. JAMA Oncol. 2016 Jun 1;2(6):737-43.