Peer-Reviewed Study Concludes Hologic’s C-View™ Software Maintains Clinical Performance of Genius™ 3D MAMMOGRAPHY™ Exam at a Lower Patient Radiation Dose
--Low Dose 3D MAMMOGRAPHY™ Exams Maintain Invasive Cancer Detection Rates and Reduce Unnecessary Patient Recalls --
For more information, visit www.LowDose3D.com

MARLBOROUGH, Mass., August 17, 2016 -- Hologic Inc. (Nasdaq: HOLX) announced today that a study by University of Pennsylvania researchers, published online in advance of print by Radiology, shows that Low Dose 3D MAMMOGRAPHY™ exams with C-View™ software are comparable to traditional Genius™ 3D MAMMOGRAPHY™ exams, with similar overall and invasive breast cancer detection, as well as recall rates.[i]

Hologic’s C-View™ software was created for physicians and patients seeking a low-dose screening option with the same clinical benefits as the Genius™ exam. With C-View™ software, a 2D image is generated using the tomosynthesis data acquired during the mammography exam, eliminating the need for additional 2D exposures. As a result, the radiation dose is lowered to one similar to conventional mammography alone, and the exam’s compression time is reduced.  

This is the first major U.S. study that compares the performance of Low Dose 3D MAMMOGRAPHY™ exams to traditional Genius™ exams. Lancet Oncology previously published findings of a European study with similar conclusions.[ii]

“We are pleased to see this Radiology paper confirm that Low Dose 3D MAMMOGRAPHY™ exams offer comparable clinical performance to our top-rated Genius™ 3D MAMMOGRAPHY™ exams, but at a dose even further below the established dose guidelines and with a faster exam time that makes it more comfortable for patients,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “This study reaffirms the efficacy of C-View™ software, and further underscores the value of 3D MAMMOGRAPHY™ exams for breast cancer screening.”

The study, led by Dr. Emily Conant, MD, from the Breast Imaging Division, Department of Radiology, Hospital of the University of Pennsylvania, compared recall rates, biopsy rates, cancer detection rates and radiation dose for 15,571 women who received a traditional Genius™ exam (digital mammography/DBT) and 5,366 women who were screened with Hologic’s Low Dose 3D MAMMOGRAPHY™ exam (synthesized 2D/DBT). Both screening methods had comparable performance, but the associated dose was significantly reduced by 39 percent with the adoption of C-View™ software. Furthermore, the low-dose screening option demonstrated an increase in the probability of a patient’s biopsy finding cancer, in comparison to traditional Genius™ exams.

“In our study, the replacement of standard 2D mammography with C-View™ 2D images in combination with a tomosynthesis exam resulted in equivalent cancer detection,” said Dr. Conant, senior author of the study. “Additionally, using synthetic 2D images resulted in a significant reduction in radiation dose while maintaining the reduction in recalls from screening.”

This study was conducted on Hologic’s Selenia® Dimensions® mammography system using the Company’s C-View™ software and as such, the results are not applicable to other manufacturers’ technology.

Hologic’s Low Dose 3D MAMMOGRAPHY™ exam with C-View™ software is CE marked, FDA approved and is commercially available in the U.S. and Europe. The Genius™ 3D MAMMOGRAPHY™ exam is only available on the Hologic Selenia® Dimensions® system. For more information, visit www.LowDose3D.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, C-View, 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 and C-View™ software. 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

 

 

[i] Zuckerman S, Conant E, Keller B, et al. “Implementation of Synthesized Two-dimensional Mammography in a Population-based Digital Breast Tomosynthesis Screening Program.” Radiology. 10.1148/radiol.2016160366

 

 

[ii] Bernardi D, Pellegrini M, Valentini 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.” The Lancet Oncology. Epub 2016 June 23.