dtectDx Breast: A serum biomarker test for breast cancer detection used in conjunction with traditional mammography screening.

18 Background: Provista Diagnostics has developed a test that analyzes serum concentrations of 5 protein biomarkers in order to detect breast cancer. The dtectDx Breast test utilizes a proprietary algorithm that has been described previously (Weber et al. 2010). In this study, it was noted that the algorithm performs best in women under age 50. The aim of this study was to evaluate the performance characteristics of dtectDx Breast in women under age 50 in a commercial setting and compare the results with data from the previous clinical study. Methods: The dtectDx Breast test measures the concentrations of IL-8, IL-12, VEGF, CEA, and HGF via ELISA. These data combined with select patient characteristics and Provista’s proprietary algorithm result in a test value that is characterized as normal or elevated. dtectDx Breast test reports issued for women under age 50 were reviewed from a 3-year time period and prescribing physicians were interviewed regarding follow-up care and outcome measures (largely imagin...