Clinical analysis of the novel breast cancer serum assay BT1

In an effort to define possible clinical relationships to the BT1 serum assay, a retrospective study population including both Caucasian and African American breast cancer patients was tested. Test results were compared to clinical information provided by the Virginia Cancer Registry. The 64 patients, ages 29 through 69, had a wide range of BT1 values which were not attributable to race or age. The majority of these patients had infiltrating duct carcinoma, with eight additional morphology of neoplasm diagnoses represented in the entire group. No morphology code was associated with either a reactive or non-reactive BT1 result. Staging information was available for 26 patients, diagnosed with stages I, II, and III breast cancer. Positive BT1 values were found throughout these diagnosis stages. In addition, multiple serum samples were available from some patients. Analysis of these longitudinal samples showed different patterns, with test values remaining unreactive in 4 patients, and reactive in 9 others. Interestingly, 5 patients showed values increasing from negative to positive while 3 patients went from positive to negative over time.