The Hologic 3D Mammography™ exam: Now FDA approved superior for women with dense breasts!

 

 

To further differentiate the Hologic 3D Mammography ™ exam from competitive tomosynthesis exams, we are thrilled to share some ground-breaking new claims that only we can deliver.  You should understand these claims and start to use them to differentiate Hologic.

 

Powerful New Density Labelling

The U.S. Food and Drug Administration (FDA) recently approved new labeling that allows us to make the following, compelling claim:

• Only the Hologic 3D MAMMOGRAPHY™ exam is FDA approved as superior for women with dense breasts compared to 2D alone.¹

This claim is important due to the fact that between 40 and 50 percent of women ages 40-74 have dense breasts, which complicates imaging, making it difficult to detect lesions, and increases the risk of breast cancer by 4-5 times .^{2, 3}

Only Hologic, and facilities with Hologic 3D Mammography™ equipment, get these results and can make these claims.

 

 

Stronger Invasive Cancer Claim

The updated invasive cancer detection claim now contains a range with a higher upper end which states that:

• The Hologic 3D Mammography ™ exam is the only mammogram clinically proven to detect 20-65 percent more invasive breast cancers compared to 2D alone, with an average increase of 41 percent.^1,4-10

Only Hologic, and facilities with Hologic 3D Mammography™ capable equipment get these results and can make these claims.

The range represents the results a facility can expect with the 3D Mammography™ exam with an upper limit of 65% making it even more impactful than our prior claim of 41% which is still the average.

 

“Effect of Age” Study

This new study, “Effect of age on breast cancer screening using tomosynthesis in combination with digital mammography,” led by Elizabeth Rafferty, MD and based on subgroup data analysis from the 2014 JAMA study, looked at the performance of tomosynthesis in specific age groups. The study showed that:

• With the addition of tomosynthesis to digital mammography, detection rates for invasive cancer increased significantly for women ages 40-69.
• At the same time, there was a significant decrease in recall rates for all age groups and the largest performance gains were seen in women age 40-49.¹¹

Only Hologic, and facilities with Hologic 3D Mammography™ equipment get these results and can make these claims.

 

¹ Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014 Jun 25;311(24):2499-507.

² Ho JM, Jafferjee N, Covarrubias GM, Ghesani M, Handler B. Dense breasts: a review of reporting legislation and available supplemental screening options. AJR Am J Roentgenol. 203(2):449-56, 2014.

³ Sprague BL, Gangnon RE, Burt V, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 106(10), 2014.

⁴ 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® system on screening outcomes. Individual results may vary.  The study found that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 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.

⁵ FDA submissions P080003, P080003/S001, P080003/S005

⁶ 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

⁷ 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.

⁸ 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.

⁹ 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.

¹⁰ Rafferty EA, Durand MA, Conant EF, et al.Breast Cancer Screening Using Tomosynthesis and Digital Mammography in Dense and Nondense Breasts. JAMA. 2016 Apr 26;315(16):1784-6.

¹¹ Rafferty E, Rose S, Miller D, et al. Effect of age on breast cancer screening using tomosynthesis in combination with digital mammography. Breast Cancer Research and Treatment – Clinical Trial – DOI 10.1007/s10549-017-4299-0.