The DiviTum® TKa Test

Metastatic Breast Cancer

 

DiviTum TKa is a test for monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients.

 

The DiviTum® TKa test has been validated for use only with serum samples from postmenopausal women previously diagnosed with HR+ metastatic breast cancer (mBC).

References:

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202852.pdf 2. Paoletti C, Barlow WE, Cobain EF, et al. Evaluating Serum Thymidine Kinase 1 in Patients with Hormone Receptor-Positive Metastatic Breast Cancer Receiving First-line Endocrine Therapy in the SWOG S0226 Trial. Clin Cancer Res. 2021; 27(22):6115-6123.
  2. Bergqvist M, et al. Thymidine kinase activity levels in serum can identify HR+ metastatic breast cancer patients with a low risk of early progression (SWOG S0226). Biomarkers. 2023; 29:1-10.
  3. Malorni L, Tyekucheva S, Hilbers FS, et al. Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer
    treated with palbociclib and fulvestrant. Eur J Cancer. 2022;164:39-51.
  4. Malorni L, Bianchini G, Caputo R, et al. Serum thymidine kinase activity in patients with HRpositive/HER2-negative advanced breast cancer treated with ribociclib plus
    letrozole: Results from the prospective BioItaLEE trial. Eur J Cancer. 2023; 186: 1–11.
  5. Krishnamurthy J, Luo J, Suresh R, et al. A phase II trial of an alternative schedule of palbociclib and embedded serum TK1 analysis. NPJ Breast Cancer.
    2022;8(1):35.
  6. Albanell J, Williams A, Martínez MT, et al. “Use of liquid biomarker thymidine kinase activity (TKa) to predict outcome and progression in patients with metastatic breast cancer (MBC) in the GEICAM/2014-12 FLIPPER trial” ASCO Annual Meeting 2024, J Clin Oncol 42, 2024 (suppl 16; abstr 1028)
  7. Howell S, Bergqvist M, Williams A, et al. “Thymidine kinase activity as a prognostic biomarker for first line CDK4/6 inhibitor efficacy in the Personalised Disease Monitoring in Metastatic Breast Cancer (PDM-MBC) study” San Antonio Breast Cancer Symposium 2024, Poster P5-02-16. 9.
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Vigilant Monitoring

 

How to interpret the test values

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