National Comprehensive Cancer Network (NCCN) Includes Breast Tomosynthesis in Breast Cancer Screening and Diagnosis Practice Guidelines

MARLBOROUGH, Mass., Aug. 1, 2016 /PRNewswire/ -- Hologic Inc. (Nasdaq: HOLX) announced today that new guidelines published by the National Comprehensive Cancer Network (NCCN) recommend that physicians consider breast tomosynthesis exams as an option for their patients' annual breast cancer screening.¹

The NCCN Guidelines, published in "NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis" are developed and updated by an impartial, physician-led group consisting of 48 individual panels and comprising over 1,150 clinicians and oncology researchers from the 27 NCCN member institutions. These panel members are multidisciplinary, disease-specific specialists who are both clinicians and researchers, and who understand the entire patient pathway, screening through treatment.

"As a practicing radiologist at an NCCN Member Institution, I'm well aware of the confusion on the part of patients and referring physicians over the best option for screening mammography," said Elizabeth Morris, M.D., Chief, Breast Imaging Service at Memorial Sloan Kettering Cancer Center. "Physicians around the globe use guidelines, like these published by NCCN, to make appropriate recommendations for their patients' care. With these in hand, referring physicians should feel more comfortable advising their patients that breast tomosynthesis is a trusted option for their annual breast cancer screening."

The NCCN Guidelines call attention to the significant body of literature that demonstrates that Hologic's breast tomosynthesis exam, the Genius™ 3D MAMMOGRAPHY™ exam, is a more accurate way to screen for breast cancer.^2,3 The guidelines, which were approved with uniform consensus (Category 2A), state that "multiple studies show a combined use of digital mammography and tomosynthesis appears to improve cancer detection and decreased call back rates. Of note, most studies used double the dose of radiation. The radiation dose can be minimized by synthetic 2-D reconstruction."¹

"Including 3D MAMMOGRAPHY™ exams as a valid mammography option for breast cancer screening is yet another confirmation of the widespread agreement among radiologists and the research literature that this screening modality increases invasive cancer detection and reduces unnecessary patient callbacks," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "Despite the strong adoption of this technology by healthcare providers, some insurance companies have refused to cover and pay for this superior screening modality in full, citing a lack of guidance and supporting research. That position is no longer valid since many insurers, including the national payers, reference NCCN guidelines in their coverage policies. We implore any major insurance company that has been reticent to provide full coverage for 3D™ exams to reconsider their position based on the new guidelines and provide the patients they cover with access to a more accurate mammogram." 

Genius™ 3D MAMMOGRAPHY™ exams have been available in the U.S. since 2011, and are only available on the Hologic Selenia® Dimensions® mammography system. In 2015, an estimated 10 million women in the U.S. benefited from a Genius™ exam. Additional information, as well as a locator to find imaging sites offering the 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.

About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network^® (NCCN^®), a not-for-profit alliance of 27 of the world's leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit NCCN.org.

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:
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¹ NCCN: NCCN Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis (Version 1.2016) © 2016 National Comprehensive Cancer Network, Inc. Available at https://www.nccn.org/professionals/physician_gls/f_guidelines.asp#breast.
² Versus 2D Mammography alone
³ Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 2014;311(24):2499-2507.

SOURCE Hologic, Inc.

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