A clinical study of pancreatic cancer patients has demonstrated that the DiviTum assay from Biovica, Uppsala, Sweden, can provide an accurate prognosis and evaluation of treatment efficacy.1
The proof-of-concept study, done in collaboration with researchers at the University of Heidelberg, provides evidence for using DiviTum as a dynamic biomarker before and during therapy to give important answers regarding prognosis and therapy efficacy. Biovica’s assay was prognostic for overall survival in all 404 patients involved in the study. For patients receiving therapy ahead of surgery, low preoperative DiviTum values correctly indicated significantly greater overall survival compared to patients with high values.
The DiviTum assay determines serum thymidine kinase 1 (S-TK) activity in a blood sample and is a noninvasive tool for predicting outcome and monitoring efficacy in solid tumors. To document the unique capabilities of the assay in solid tumors, Biovica has an ongoing trial program including more than 10 clinical studies and 1,500 patients.
“It is very important to know if a therapy is effective or not,” says Klaus Felix, PhD, of the department of general surgery at the University of Heidelberg. “The results provide evidence for using DiviTum to give accurate prognosis and guidance regarding therapy efficacy in patients with pancreatic tumors. Our study is the first to demonstrate that a blood-based marker like DiviTum can give important prognostic information to clinicians treating pancreatic cancer and become a tool for early evaluation of neoadjuvant therapy efficacy and treatment options.
“Additionally, despite the fact that CA 19-9 is still the gold standard biomarker in pancreatic cancer, for patients with low CA 19-9 or CA 19-9 nonsecretors, the S-TK assay could be an alternative screening marker,” Felix adds.
“The results presented from our collaboration with Dr Felix at the University of Heidelberg demonstrates the utility of DiviTum for precise prognosis and therapy efficacy evaluation for patients with pancreatic cancer,” says Anders Rylander, CEO of Biovica. “This builds on already published data on other tumors and provides evidence beyond our extensive trial program in breast cancer, with the aim for DiviTum to become a standard tool for predicting outcome and early efficacy evaluation for patients with specific solid tumors.”
For more information, visit Biovica.
- Felix K, Hinz U, Dobiasch S, et al. Preoperative thymidine kinase activity as novel monitoring, prognostic, and predictive biomarker in pancreatic cancer. Pancreas. 2018;47(1):72–79; doi: 10.1097/mpa.0000000000000966.