-- Addition of tomosynthesis increased breast cancer detection and simultaneously reduced recall rates

BEDFORD, Massachusetts, May 8, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products with an emphasis on serving the healthcare needs of women, today announced the publication of the final results of a large-scale prospective study comparing breast cancer screening using Hologic's 2D mammography plus tomosynthesis (Breast Tomosynthesis) with conventional 2D mammography published online in advance of print by The Lancet Oncology.

The study, "Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study,"^[i] was led by a team of Italian and Australian researchers, represented by Associate Professor Nehmat Houssami, at the University of Sydney's School of Public Health in Australia. The study investigated whether integrated 2D mammography with tomosynthesis was more effective at detecting cancers and reducing false positives than 2D screening alone. The analysis was based on the exams of 7,292 women with an average age of 58 who were screened at two sites in Italy.

The use of Hologic's Breast Tomosynthesis technology significantly increased cancer detection rates and simultaneously reduced false positives. Significant findings include:

• Breast Tomosynthesis identified 8.1 cancers per 1,000 screens, compared with 2D mammography alone at 5.3 per 1,000 screens, an increase in the number of cancers detected by over 50%.
• Breast Tomosynthesis resulted in a simultaneous 17% recall rate reduction.

"It is very encouraging to see this new, additional confirmation of the compelling benefits of 3D mammography," says Dr. Edward Lipsit, President of Washington Radiology Associates, the world's largest provider of 3D mammography. "We have used 3D mammography as a screening tool for breast cancer since August 2011 and we see the positive impact of this technology on a daily basis. Not only are we finding cancers earlier, when they are easiest to treat, we're also eliminating much of the stress and expense associated with false positive recalls. My colleagues and I firmly believe the addition of 3D mammography to a screening exam could become the acknowledged standard of care. The clinical data that continues to emerge, including the latest study from Italy, provides strong, powerful support for this position."

"The Italian Screening Tomosynthesis or Mammography (STORM) data underscores the clinical benefits of integrated 2D and tomosynthesis breast screening," said Peter Soltani, Hologic Senior Vice President and General Manager, Breast Health. "The statistically significant increase in cancer detection and reduction in false positives reinforces the results of previously published papers such as the Oslo tomosynthesis screening trial. As more clinical studies are published, the importance of including Hologic's Breast Tomosynthesis technology in screening examinations will become more widely recognized and accepted by physicians and patients. Early detection of breast cancer greatly influences a woman's chances for successful treatment and the ability to decrease the number of unnecessary recalls helps reduce patient anxiety. We believe our tomosynthesis technology sets the standard of care in breast cancer screening and diagnosis."

Hologic's Breast Tomosynthesis technology has been approved for use in countries recognizing the CE mark since 2008. It was approved for use in the U.S. for breast cancer screening and diagnosis in February, 2011. Hologic systems are now in use in 48 states in the U.S. and over 50 countries.

For more information about Hologic's Breast Tomosynthesis technology, please visit www.BreastTomo.com (for healthcare providers) and www.Hologic3D.com (for patients).

About Hologic, Inc.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems, and surgical products. The Company operates four core business units focused on diagnostics, breast health, GYN surgical and skeletal health. With a comprehensive suite of technologies and a robust research and development program, Hologic is committed to improving lives. The Company is headquartered in Massachusetts.

Hologic is a trademark and/or registered trademark of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statement Disclaimer.

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic digital mammography systems. There can be no assurance the systems will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as 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. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein 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.

^{[i] Ciatto S, Houssami N, Bernardi D, Caumo F, Pellegrini M, Brunelli S, Tuttobene P, Bricolo P, Fanto C, Valentini M, Montemezzi S, Macaskill P. Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study. The Lancet Oncology. Published online in advance of print, April 25, 2013.}

SOURCE Hologic, Inc.