Clinical Evidence

* Presented studies (all others are published)

All Studies = Prognostic
Pre = Predictive
Mon = Monitoring
ET = Endocrine Therapy
CDK = CDK4/6 inhibitors

Published Studies for the DiviTum® TKa Test

The DiviTum® TKa test has been studied widely in HR+ metastatic breast cancer, as well as in other solid tumor types. The evidence demonstrates that measuring thymidine kinase activity (TKa) levels with the DiviTum TKa test provides important clinical information for the management of the disease.

24+ publications support the application of DiviTum® TKa to prognose, predict, and monitor response to anti-cancer agents such as endocrine therapies and CDK4/6 inhibitors.

Metastatic Breast Cancer

TKa patterns provide clinical utility by predicting and monitoring the efficacy of ET with or without CDK4/6 inhibitors.

Serum thymidine kinase activity in patients with HR-positive/HER2-negative advanced breast cancer treated with ribociclib plus letrozole: Results from the prospective BioItaLEE trial. [EJC, June 2023]

Thymidine kinase activity levels in serum can identify HR+ metastatic breast cancer patients with a low risk of early progression (SWOG S0226). [Biomarkers, January 2023]

Circulating tumor DNA (ctDNA) and serum thymidine kinase 1 activity (TKa) matched dynamics in patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor 2–negative (HER2-) advanced breast cancer (ABC) treated in first-line (1L) with ribociclib (RIB) and letrozole (LET) in the BioItaLEE trial. [Journal of Clinical Oncology, June 2022]

A phase II trial of an alternative schedule of palbociclib and embedded serum TK1 analysis. [NPJ Breast Cancer, March 2022.]

Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant. [European Journal of Cancer, March 2022]

Evaluating Serum Thymidine Kinase 1 in Patients with Hormone Receptor-Positive Metastatic Breast Cancer Receiving First-line Endocrine Therapy in the SWOG S0226 Trial

Other Malignancies

CLL, lymphoma, multiple myeloma

NSCLC, SCLC, benign lung disease

Pancreatic cancer, RCC, melanoma, solid tumors (general)


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