Clinical Utility of Breast Cancer DNA Markers in Plasma

It has become more apparent that in cancer patients, identification of genetic changes in tumors can be highly informative in assessing the outcome of treatments. Multiple genetic changes are required for tumors to start growing, continuing growing and become more aggressive. Although multiple genetic markers in breast cancer have been defined, studies of how they can be used to diagnose breast cancer and predict disease progression are still limited. However, genetic changes (DNA markers) in breast cancer should prove to be valuable as prognostic tools. Traditionally genetic markers are tested only in tumors that have been surgically removed, which limits the assessment of the disease progression to the genetic status of the tumor when it was removed. We have developed an innovative molecular diagnostic assay to assess multiple genetic markers in a small amount of blood (less than 5 ml) from breast cancer patients. This assay provides a unique approach in monitoring genetic changes occurring during tumor progression without the need to obtain tumor tissue through invasive surgical procedures. The assay is highly informative, more tumor-specific than conventional assays, provides an inexpensive means of rapid testing, and offers an improved method for diagnosis and prognosis of breast cancer disease. By correlating these genetic analyses with clinico-pathological factors, the assay provides an exciting new approach for assessing breast cancer progression.