The review included 18 studies with data from nearly 3,000 women, with 15 studies included in the meta-analysis. All eligible studies used Biovica’s DiviTum® TKa assay to measure TKa in blood.

The results showed a clear relationship between TKa levels and patient outcomes. Patients with high TKa before starting treatment had approximately twice the risk of disease progression and more than twice the risk of death compared with patients with low TKa.

TKa measured shortly after treatment had started also provided important information. High TKa at two and four weeks was associated with a substantially higher risk of disease progression, supporting the potential of TKa to provide early information about how a patient’s disease is developing during treatment.

“This publication further strengthens the growing body of evidence for DiviTum TKa. By bringing together data from multiple studies, it demonstrates the consistency of TKa as an indicator of tumor proliferation and its association with patient outcome. This strengthens confidence in the biomarker, both for clinical use and as a tool in oncology drug development, where better biomarkers are needed to understand treatment effect earlier and support more informed development decisions,” said Theis Kipling, CEO of Biovica.

The authors conclude that the meta-analysis provides the strongest evidence to date supporting the clinical validity of circulating TKa as a prognostic biomarker in HR+ metastatic breast cancer.

The article, “Prognostic role of thymidine kinase 1 activity in hormone receptor positive metastatic breast cancer. A systematic review and meta-analysis”, was published in The Breast.