Evaluation of the BT-1 serum assay for breast cancer

Abstract

The BT-1 assay which identifies a novel breast tumor associated serum analyte was performed for 143 patients previously diagnosed with breast cancer. Mucin tumor markers CA15-3/CA27-29 values were available for 50 patients and there was very minor overlap between patients positive by both tests. Patients' follow-up clinical status at sample draw was compared to BT-1 assay results. 27% patients originally diagnosed as Stage III who were evaluated ‘no disease’ had positive BT-1 values. 8% results in samples drawn within 90 days of chemotherapy initiation, whereas 23% 90 days of chemotherapy initiation. 50% breast cancer surgery had positive BT-1 values, suggesting that the BT-1 assay may be useful in identification women with more advanced disease at diagnosis.