CADx Medical Systems, a subsidiary of Shire Pharmaceuticals Group plc has received approval from the U.S. Food and Drug Administration (FDA) for its Second Look computer-aided detection (CAD) system for mammography that improves breast cancer detection. The FDA approval is for both screening and diagnostic use and allows CADx to immediately commercialize this new and exciting technology to hospitals, clinics and mammography centers around the United States.

"Second Look helps radiologists identify subtle changes in tissue that may indicate the presence of cancer," said Greg Arnsdorff, president of CADx Medical Systems. "The Second Look system easily integrates with existing radiology practices, and is highly effective at boosting detection rates."

The data reviewed by the FDA for this approval were generated in a large, multicenter trial of approximately 9000 patients performed at 18 leading medical institutions across the United States. In the clinical trials, 26.2 per cent of breast cancers missed would be detected with the use of Second Look.

"The key to effective treatment for many women with breast cancer often relies on finding cancerous tumors early, before they spread to other parts of the body," said Dr. Rachel Brem, Director of Breast Imaging and Intervention at The George Washington Medical Center. "Since mammography is the most powerful tool we have to detect breast cancer early, every improvement in accuracy and sensitivity has important ramifications for our patients and medical practice. Taking a 'second look' at suspicious tissue potentially means more lives could be saved."