Thymidine Kinase 1 as an Early Predictor of Breast Cancer : A Simulation Study

Sammanfattning

Breast cancer remains a major cause of morbidity and mortality among women worldwide, with a need for improved early detection methods beyond conventional mammography. This study evaluates the potential role of the thymidine kinase 1 activity assay, DiviTum®TKa, both as a standalone screening tool and as a complement to MAM. Using Monte Carlo simulation methods, the sensitivity and specificity of DiviTum®TKa were assessed based on real-world data of healthy individuals and breast cancer patients at various stages. The standalone test demonstrated limited diagnostic performance, with an area under the curve of 0.56, sensitivity of 0.34, specificity of 0.88, and a low positive predictive value of 1.9%, indicating insufficient capability for clinical screening. When combined with MAM, DiviTum®TKa improved true positive rates, particularly within the BI-RADS 4 category, yet at the expense of increased false positives, notably in the BI-RADS 1 category. The study highlights that while the results indicate a possible role for DiviTum®TKa in improving cancer detection, the findings are limited by the use of non-validated "apparently healthy" individuals and the lack of treatment status. Further research using clinically verified test groups and prospective data is necessary to confirm the test’s clinical utility in screening programs.