News | Breast Imaging | October 02, 2017

Company highlights recent milestones including new breast biopsy and stabilization system launches

Hologic rings Nasdaq bell for breast cancer awareness

October 2, 2017 — Hologic Inc. announced that Steve MacMillan, the company's chairman, president and CEO, joined selected employees to ring the Nasdaq Opening Bell on October 2 in conjunction with the start of Breast Cancer Awareness Month. This is the 12th consecutive year Hologic rang the bell for Breast Cancer Awareness Month.

Earlier this year, the Genius 3-D Mammography exam was approved by the U.S. Food and Drug Administration (FDA) as superior to standard 2-D mammography for routine breast cancer screening for women with dense breasts.[1],[2],[3],[4] This updated labeling was based on clinical studies proving that the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts. The expanded labeling also provides clarity for physicians who previously were unsure how to screen patients with dense breasts.

Other milestones in the last 12 months include two recent product launches, the Brevera breast biopsy system with CorLumina imaging technology and the SmartCurve breast stabilization system. The Brevera system is the world's first and only breast biopsy solution to combine tissue acquisition, real-time imaging, sample verification and advanced post-biopsy handling in one, integrated system, according to Hologic. The system allows physicians to perform fast and efficient procedures that save costs, improve the patient experience, and enhance workflow in the biopsy suite.[5]

Hologic's new SmartCurve system, when used with the Genius exam, is the first and only 3-D mammography system clinically proven to deliver a more comfortable and more accurate mammogram, compared to 2-D mammography alone, according to the company.[6] In a recent clinical study comparing the SmartCurve breast stabilization system to traditional flat paddle compression, the SmartCurve system improved comfort in 93 percent of women who reported moderate to severe discomfort with standard compression.[5]

The Genius 3-D Mammography exam (also known as the Genius exam) is only available on a Hologic 3-D mammography system. It consists of a 2-D and 3-D image set, where the 2-D image can be either an acquired 2-D image or a 2-D image generated from the 3-D image set.

For more information: www.hologic.com

 

References

[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] 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.

[3] 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% (95% CI: 20-65%) increase and 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.

[4] U.S. Food & Drug Administration Premarket Approval (PMA).  FDA.gov https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P08… June 5, 2017.

[5] 3D biopsy only when used with the Affirm breast biopsy system.

[6] Smith, A. Improving Patient Comfort in Mammography. Hologic WP 00119 Rev 001 (2017).

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