Early detection of breast cancer using a unique tumor specific antibody.

e22153 Background: Breast cancer (BC) remains the second leading cause of cancer-related deaths for women in the US. Mammography has improved early detection, but can miss up to 25 percent of BC since mammogram sensitivity is less than 50% in women with dense breast tissue. BC is often detected in these women when a lump is discovered and the cancer is late stage. There is a critical need for an accurate diagnostic for these women. The tumor form of MUC1 (designated TMUC1),a transmembrane glycoprotein, is aberrantly glycosylated and overexpressed in ~95% of BC. We have developed an antibody (TAB004), which specifically recognizes TMUC1. Methods: 1) Using TAB004, a GMP-grade ELISA kit was used to test circulating levels of TMUC1 in sera of patients. We have tested ~250 patient sera (includes normal, benign, and malignant) collected from Duke University Cancer Center, National Cancer Institute (NCI), Early detection research network (EDRN) reference set, and Fox Chase Biorepositories. The samples represente...