UPPSALA, SE / ACCESS Newswire / November 26, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Biovica, a leader in blood-based cancer monitoring, today announces the presentation of two new abstracts at the 2025 San Antonio Breast Cancer Symposium (SABCS). Both studies highlight the clinical relevance of DiviTum TKa as a dynamic biomarker for monitoring treatment response and pave the way for increased clinical uptake of the test.
"These studies further demonstrate the value of DiviTum TKa as a practical and actionable tool that supports clinicians in making precise and timely treatment decisions. By offering real-time insights into treatment effect and helping identify issues such as drug-drug interactions or resistance, DiviTum TKa are contributing to improved care for patients with metastatic breast cancer," said Anders Rylander, CEO of Biovica.
"The DiviTum TKA assay is a promising tool for monitoring adherence to CDK4/6 inhibitors and drug-drug interactions in the clinic," said Mariya Rozenblit, MD Assistant Professor of Medicine (Medical Oncology) Yale School of Medicine.
"Our study indicates that the TKa assay provides a dynamic, non-invasive way to monitor response to CDK 4/6 inhibitor-based therapy and, when paired with baseline ctDNA, can help identify patients at risk of early progression," said Dr. Elena Michaels at MGB Cancer.
In both studies, DiviTum TKa, a blood-based assay measuring thymidine kinase activity (TKa), was used for patients with hormone receptor-positive, HER2-negative metastatic breast cancer (HR+/HER2- mBC) receiving CDK4/6 inhibitor therapy. The results will be presented at the San Antonio Breast Cancer Symposium, SABCS 2025 (December 9-12).
More on the studies:
Monitoring adherence and drug interactions with DiviTum TKa
Researchers from Yale Cancer Center evaluated whether early TKa measurements could identify suboptimal CDK4/6 inhibitor activity caused by medication non-adherence or drug interactions. In this single-institution pilot study of 30 patients:
83% achieved TKa suppression (<100 DuA) by Cycle 2 Day 28, correlating with prolonged progression-free survival.
Persistently elevated TKa levels early in treatment predicted poor outcomes (median PFS 2.5 months).
In several cases, elevated TKa revealed practical issues such as incorrect dosing or interacting medications, which were corrected to restore suppression.
Linking tumor genomics and TKa response patterns
A multi-center case series from Massachusetts General Hospital Cancer Center and Washington University explored associations between baseline circulating tumor DNA (ctDNA) profiles and early TKa response patterns in 22 patients initiating CDK4/6 inhibitor therapy:
Three distinct TKa patterns were observed: suppressed, rebound, and unsuppressed. The latter two were associated with inferior outcomes.
Baseline ctDNA revealed resistance-associated alterations, including AKT/PTEN, TP53, ERBB2, and ESR1 mutations.
Notable cases demonstrated how integrating ctDNA and TKa may provide complementary insights-ctDNA reveals resistance biology, while TKa reflects real-time treatment effect.
Contact
Anders Rylander, CEO
Phone: +46 76 666 16 47
E-mail: anders.rylander@biovica.com
Anders Morén, CFO
Phone: +46 73 125 92 46
E-mail: anders.moren@biovica.com
Biovica - Treatment decisions with greater confidence
Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica's assay, DiviTum TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: "Improved care for cancer patients." Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: www.biovica.com
Attachments
Two new studies with DiviTum TKa presented at SABCS 2025
SOURCE: Biovica International
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/two-new-studies-with-divitum-tka-presented-at-sabcs-2025-1112360
