Hologic Receives FDA 510(k) Clearance for R2 Quantra™ Volumetric Breast Density Assessment

BEDFORD, Mass., Sept. 30, 2008 /PRNewswire-FirstCall/ -- Hologic, Inc. (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that it has received Food and Drug Administration (FDA) clearance for the R2 Quantra volumetric breast density assessment tool.

Quantra is a software application intended for use with Hologic digital mammography systems that provides radiologists with an automated method for assessing breast density. It creates an internal 3D model of the breast from which it derives estimates of the fibroglandular tissue volume and total breast volume; volumetric breast density is the ratio of these values. Using the Quantra tool to provide numeric values for each breast may aid radiologists in the assessment of breast tissue composition without the subjectivity of human interpretation.

According to research published in Journal of the National Cancer Institute1 , new models for predicting a woman's risk of developing breast cancer find that breast density is a highly clinically significant predictor of breast cancer risk that is almost as powerful a risk factor as age2. Prior to the development of Quantra software, there has not been a consistent breast density assessment method available to clinicians.

"The recent FDA clearance of the Quantra breast density assessment application provides radiologists with a clinical tool to assess breast density and should facilitate better breast cancer risk assessment models for the future," said Dr. Ronald A. Castellino, Chief Medical Officer for Hologic. "Current clinical breast density assessment methods do not offer a consistent way to assign breast density categories as they tend to focus on human observations of density, rather than numeric measures of density. The Quantra tool should provide researchers with the information they need to conduct further research on breast density's true relationship with breast cancer."

FDA clearance of the R2 Quantra volumetric breast density assessment application was received in September 2008. The product will be available in the U.S. market in October 2008.

About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging, and molecular diagnostic products including reagents for a variety of DNA and RNA analysis applications.

Forward Looking Statement Disclaimer
This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect of the use of Hologic's R2 Quantra volumetric breast density assessment on breast cancer patients. There can be no assurance that the Quantra application will provide improved breast cancer risk assessment. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such data or statements presented herein to reflect any change in Hologic's expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect Hologic's business and prospects are described in Hologic's filings with the Securities and Exchange Commission.


1 Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute.

2 Ariel Whitworth, Press Release: Breast Density Helps Predict Breast Cancer Risk, J Natl Cancer Inst, Sep 2006; 98: 1167.


Contact:
James D. Culley, Ph.D.
Director, Corporate Marketing
Hologic, Inc.
Tel: 781.999.7583


Julian Marshall
Director, Product Management & Principal Engineer Computer Aided Detection
Hologic, Inc.
Tel: 650.224.8484