U.K. Study Reports 6.5% More Breast Cancers Detected by Radiologists Using Computer Aided Detection Compared to Double Reading
The CAD System Used in This Study Was Supplied by Hologic's R2 Technology Subsidiary

BEDFORD, Mass., Oct. 5, 2006 /PRNewswire-FirstCall/ -- Hologic, Inc. (NASDAQ: HOLX), a leading provider of diagnostic imaging and state-of-the-art digital imaging systems directed towards women's health, today announced that according to a new study titled "Single reading with computer-aided detection and double reading of screening mammograms in the United Kingdom National Breast Screening Program" published in the October issue of Radiology*, the performance of a radiologist using computer aided detection (CAD) was superior to that of screening mammograms which were double read. This landmark study by researchers from two leading breast centers in the United Kingdom measured radiologists' performance with the use of CAD. The study also showed a 15% increase in cancer detection rates when CAD was used. The CAD system (ImageChecker® 1000 version 5.0) used in this study was supplied by Hologic's R2 Technology subsidiary.

The CAD program scans a mammogram for suspicious features or abnormalities that could represent breast cancer. When the computer finds anything unusual it indicates the abnormality on a screen for the radiologist to check. The CAD system used in this study features proprietary R2 EmphaSize™ software, which provides variable size marks that correlate to lesion significance. A larger mark indicates that the CAD algorithm detects more mammographic features that are indicative of cancer. The marks prompt the radiologist to double check suspicious areas, particularly focusing on features with larger CAD marks.

The study included a sample of more than 10,000 mammograms obtained from women aged 50 years or older who underwent routine screening. Mammograms that were double read initially were randomly allocated to be re-read by eight different radiologists using a single read and CAD. Cancer detection rates and recall rates from double reading and single reading with CAD were then compared. The researchers found that single reading with R2 CAD detected 6.5% more cancers -- a 15% increase in the cancer detection rate -- than that achieved with double reading (P=0.02)

Professor Fiona Gilbert, of Aberdeen University, who led the study, said: "The results of this trial are very encouraging. The mammograms studied were from a sample taken in 1996 so that all cancers that developed subsequently in this group of women could be included. The study was retrospective so the radiologists taking part in the trial knew no action would be taken as a result of their decisions."

"We have now embarked on a new study to confirm that the CAD result is still as good when used in real day to day decision making about breast cancer diagnosis," Professor Gilbert added.

Dr. Sue Astley of Manchester University who also worked on the study said: "This new prospective trial will involve 30,000 women in three major screening centers, most of whom will have single reading with CAD in addition to their routine double reading. This is an opportunity for women in the UK to have their mammograms read using the latest CAD technology which is already available in America and other countries."

The R2 ImageChecker was the first CAD system approved by the U.S. Food and Drug Administration (FDA) for use with film-based mammography in 1998 and for digital mammography in 2001. Since 1998, the company has received multiple supplemental approvals for technological and clinical advances and owns or has exclusive worldwide rights in more than 115 issued and pending patents. To date, more than 2,500 ImageChecker mammography CAD systems have been sold worldwide and this year, R2 estimates that approximately ten million women will have their mammograms interpreted with the aid of R2's leading technology.

About Hologic

Hologic Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for digital radiography and breast imaging. Hologic's core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C- arm and extremity MRI imaging for orthopedic applications. Hologic's R2 Technology subsidiary is a recognized leader in the development and commercialization of computer-aided detection (CAD), an innovative technology that assists physicians in the earlier detection of breast cancer, actionable lung nodules and other lung abnormalities. Dedicated to diagnostic decision support, increasing physician productivity and preventing medical errors, R2 Technology is developing CAD systems for a variety of imaging modalities and disease states. For more information, visit and

ImageChecker is a registered trademark of R2 Technology, Inc.

Gilbert FJ, Astley SM, McGee MA, Gillan MGC, Boggis CRM, Griffiths PM and Duffy SW. "Single reading with computer-aided detection and double reading of screening mammograms in the United Kingdom National Breast Screening Program." Radiology 2006; 241: 47-53

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SOURCE: Hologic, Inc.