Strategic approach to validating methylated genes as biomarkers for breast cancer.

Although the potential of biomarkers to aid in the early detection, diagnosis, prevention, and treatment of breast cancer is broadly recognized and numerous biomarker candidates have been reported in the literature, few molecular markers have been adopted into clinical use to date. To address this lack of translation of biomarkers from the bench to clinical practice, the Cancer Biomarkers Research Group in the Division of Cancer Prevention of the National Cancer Institute organized a meeting, "Strategic Discussion on Biomarkers for Breast Cancer," which was held at the Fred Hutchinson Cancer Research Center on September 14, 2008. Participants included industry leaders, basic and physician scientists, and National Cancer Institute program staff. The objectives of this strategic discussion were to define clinical uses and needed performance characteristics of biomarkers; to identify novel approaches to discover and validate breast cancer biomarkers, particularly those with improved chances of being clinically useful; and to identify candidate DNA methylation markers that could be taken forward for validation. Participants presented and recommended methylation biomarkers suitable for initiating collaborative projects to evaluate the markers for future clinical application. This commentary summarizes their discussions and recommendations and the rationale for initiating specific projects to validate DNA methylation biomarkers of breast cancer.