The DiviTum TKa blood test is FDA 510(k) cleared in the US and CE marked in Europe

The DiviTum^® TKa test

Unlike Any Other Blood-based Tumor Marker

The DiviTum^® TKa test quantifies the level of thymidine kinase activity in the bloodstream from proliferating tumor cells. This generates a DiviTum activity score which can offer important insights about the proliferative status of a patient’s disease.

Next-Level Monitoring of BC Patients

The DiviTum^® TKa test is an innovative tumor TK activity (TKa) profile test for early prognosis and prediction of mBC treatment outcomes in postmenopausal HR+ mBC patients.^1-4

Now also available in the US for Early Breast Cancer.^5,6

How to Order

Fills the Current Imaging Gap

The DiviTum^® TKa test can provide clinicians with information about changes in tumor cell proliferation in response to therapy many months before a change in tumor volume is detectable by imaging.

– Assesses non-measurable disease that may not be detected with conventional imaging.
– With measurable disease, assessing TKa may complement and improve diagnostic accuracy when imaging results are equivocal.

Clinical Evidence

Thymidine kinase (TK) plays a key role in DNA synthesis and cell proliferation. Studies have shown that TK activity (TKa) is elevated in actively proliferating cancer.

The Science Behind TKa

The DiviTum^® TKa test can help health care providers determine which patients are—or are not—responding optimally to CDK4/6 inhibitor therapy and may benefit from continuing therapy.

Clinical Benefits

The DiviTum^® TKa test can help oncologists make confident treatment decisions

Allows health care providers to track a patient’s response early on—and at any time
point as clinically indicated throughout treatment.

Complements traditional imaging—particularly if CT scans are difficult
to interpret; assesses non-measurable disease that may not be
detected with conventional imaging

DiviTum TKa is a tool that can help guide more personalized treatment strategies for post-menopausal women diagnosed with HR+ metastatic breast cancer.

References

1. 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 January 2023

2. Paoletti C, 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.

3. Malorni L, et al. International Breast Cancer Study Group; Breast International Group and PYTHIA Collaborators. 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, et al. 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. Eur J Cancer. 2023; 186: 1–11. Eur J Cancer 2023; 186: 1–11.

5. Williams A, Bear H, Denkert C, et al. “Evaluation of proliferation biomarker serum thymidine kinase activity and prediction of early relapse in HR positive HER2 negative high risk early breast cancer: Analysis from the PENELOPE-B trial” San Antonio Breast Cancer Symposium 2024, Poster P1-09-06.

6. Witkiewicz A, Schultz S, Knudsen ES et al. “Interrogating serum thymidine kinase activity with CDK4/6 inhibitor based therapies: real-world experience in the metastatic and adjuvant setting” San Antonio Breast Cancer Symposium 2024, Poster P2-05-16.