he proof of concept study, including 404 patients, provides evidence for using DiviTum as a dynamic biomarker before and during therapy to give important answers regarding prognosis and how effective therapy is.
Uppsala, Sweden, November 21, 2017. In collaboration with University of Heidelberg, Germany, results from a clinical study of pancreatic cancer is published in the Pancreas scientific journal. The results demonstrate that Biovica’s DiviTum assay can provide an accurate prognosis and evaluation of treatment efficacy.
The proof of concept study, including 404 patients, provides evidence for using DiviTum as a dynamic biomarker before and during therapy to give important answers regarding prognosis and how effective therapy is. Biovica’s assay was prognostic for overall survival in all patients. For patients receiving therapy ahead of surgery, preoperative low DiviTum values demonstrated significantly higher overall survival compared to patients with high values.
Pancreatic cancer is one of the deadliest forms of cancer. Hence, tools that can provide more and early information regarding the disease is in great need. With better and faster evaluation of treatments Biovica aims to provide a better tool when evaluating therapy options. The study provides additional evidence and future expanded clinical potential outside of breast cancer for DiviTum.
The DiviTum assay determines thymidine kinase activity in a blood sample and is a practical, non-invasive tool for predicting outcome and monitoring efficacy in solid tumors. Biovica have an ongoing trial program including more than 10 clinical studies and 1 500 patients to document the unique capabilities of the assay in solid tumors.
“It is very important to know if a therapy is effective or not. 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 non-secretors, the S-TK assay could be an alternative screening marker”, says Dr Klaus Felix, Ph.D, Department of General Surgery, University of Heidelberg.
“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. 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”, says Anders Rylander, CEO Biovica.
More information:
Anders Rylander, CEO Biovica.
Phone: +46 (0)18 444 48 35,
E-mail: anders.rylander@biovica.com
This information is information that Biovica International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person(s) set out above, at 08.00 CET on November 21, 2017.
About Biovica
Biovica develops and commercializes blood-based biomarker assays that improve monitoring of modern cancer therapies and predict patient outcome. The company’s DiviTum® assay, a test for accurately measuring cell proliferation, has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. Biovica aims to make best-possible-treatment from day one a reality.
Biovica collaborates with world-leading cancer institutes as well as pharmaceutical companies launching next-generation therapies. The company is ISO 13485 certified for Quality Management Systems. DiviTum® is CE-labeled and MPA-registered. Appointed Certified Adviser to the company is FNCA Sweden AB.
