Quantitative Test for the Evaluation of Metastatic Tumor Proliferation

Divitum TKa Utilities

The DiviTum® TKa test measures the activity of thymidine kinase 1 (TK1) in the blood, an enzyme released by proliferating tumor cells. The result is a DiviTum activity score, which provides valuable information about the proliferative status of the patient's disease. It is particularly useful for early prognosis and assessing treatment efficacy in patients with HR+ metastatic postmenopausal breast cancer.

Divitum TKa is a CE IVD certified kit

DiviTum® TKa is a certified in vitro diagnostic medical device (CE IVD).
The test is performed on serum obtained from blood samples and is based on a multi-step endpoint ELISA technology, which analyzes a cascade of enzymatic reactions to quantify the level of thymidine kinase activity.

Sensitivity and specificity

Clinical studies demonstrate that a patient with a negative test result has a 97% chance of not experiencing tumor progression in the next 30 days.
The reduced probability of progression within 30 or 60 days of testing suggests the use of DiviTum TKa as a complementary tool to imaging, especially in the periods between one radiological examination and the next.

Procedure

The procedure for performing the Divitum TKa test involves the following steps:

The data obtained from the ELISA test are processed directly by the microplate reader, which provides the final Divitum data.

The result of Divitum TKa

The DiviTum® TKa test can provide clinicians with insights into changes in tumor cell proliferation in response to therapy, months earlier than conventional imaging. It is particularly useful in cases of non-measurable disease, which may be missed by traditional radiological techniques. Even in the presence of measurable disease, TKa activity analysis can complement imaging, helping clarify diagnostic questions and improving the overall accuracy of the assessment.

Bibliography

Paoletti C, et al. Clin Cancer Res. 2021 Nov 15;27(22):6115-6123
Bergqvist M, et al. Biomarkers, 2023, DOI: 10.1080/1354750X.2023.2168063
Bitter EE, et al. Cell Biosci. 2020;10(1):138.
Larsson AM, et al. Sci Rep. 2020;10(1):4484
Gaughran G, et al, Breast Cancer Management, 2023 https://doi.org/10.2217
Krishnamurthy J, et al. npi Breast Cancer 8, 35 (2022)

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