Systematic Review of Literature Further Validates that Breast Tomosynthesis Reduces False Positives and Increases Detection of Invasive Breast Cancer
Review Analyzes Five Studies Using Hologic’s Genius™ 3D MAMMOGRAPHY™ Exams
PR Newswire
HOLX

MARLBOROUGH, Mass., April 5, 2016 – Hologic, Inc. (Nasdaq: HOLX) announced that the first systematic review of breast tomosynthesis literature has published online in advance of print in The Breast. The review underscores prior studies’ findings that 3D MAMMOGRAPHY™ exams, consisting of breast tomosynthesis plus digital mammography, are found to have a higher rate of invasive cancer detection and a lower rate of false positives than digital mammography alone.1

The review, “Systematic review of 3D mammography for breast cancer screening,” examined all relevant literature through October 2014, including all major screening trials conducted in Europe and the U.S., and found five studies from Italy, Norway and the U.S. eligible for inclusion. Conducted by the globally recognized York Health Economics Consortium, the authors are from leading research sites in the United Kingdom (University of York), Germany, (Referenzzentrum Mammographie Munchen) and the United States (the Johns Hopkins University School of Medicine). The review concludes that the majority of the studies conducted on this topic have been of high quality with very low risk of bias.

Stephen Rose, MD, author of one of the major breast tomosynthesis papers reviewed in this study, said, “While there has been excellent literature published about the benefits of breast tomosynthesis with digital mammography, there hadn’t yet been an aggregation of the papers to analyze their conclusions, methodology and design. As a practicing radiologist and an early adopter of tomosynthesis exams, I’m delighted to report that the benefits of this technology — reducing the rate of false positives and finding invasive cancer earlier — withstood the rigors of this review and continue to offer these important benefits to patients and those charged with protecting public health.”

“As this systematic review clearly shows, 3D MAMMOGRAPHY™ exams are well-established and clinically superior for breast cancer screening,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “The review confirms the benefits of the Genius 3D MAMMOGRAPHY™ exam and demonstrates that women everywhere should have access to this important screening.”

The Genius 3D MAMMOGRAPHY™ exam is only available on the Hologic Selenia® Dimensions® system. Currently, women in more than 30 countries have access to this life-saving technology, which is clinically proven to reduce patient callbacks by up to 40 percent2,3 and detect 41 percent more invasive breast cancers.2 Additional information, as well as a locator to find U.S. imaging sites offering Genius™ exams, can be found at http://mygenius3d.com/.


About Hologic
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company’s core business units focus on diagnostics, breast health, GYN surgical and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.
Hologic, 3D, 3D Mammography, Dimensions, Genius, Selenia and the Science of Sure are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.


Forward-Looking Statements
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic mammography systems. There can be no assurance the systems will achieve the benefits described here, or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that the systems will achieve any expected level of sales or market share. Hologic expressly disclaims any obligation to release publicly any updates to the data or statements presented here to reflect any change in the Company’s expectations or any change in events, conditions or circumstances on which any such data or statements are based.

Media Contact:
Jane Mazur
508.263.8764 (direct)
585.355.5978 (mobile)
jane.mazur@hologic.com

Investor Contact:
Michael Watts
858.410.8588
michael.watts@hologic.com

References: 1. Hodgson R, Heywang-Kobrunner S, Harvey S, et al. Systematic Review of 3D Mammography for Breast Cancer Screening. The Breast. 2016;27:52-61 [epub ahead of print]. 2. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014;311(24):2499-2507. 3. Rose SL, Tidwell AL, Bujnoch LJ, et al. Implementation of breast tomosynthesis in a routine screening practice: an observational study. AJR Am J Roentgenol. 2013;200(6):1401-1408.