STOCKHOLM, Sweden, May 28, 2026
Biovica, a company focused on blood-based cancer monitoring technologies, announced new translational research published in the European Journal of Cancer showing that its FDA 510(k)-cleared DiviTum® TKa assay can identify early treatment-specific biological responses in patients with endocrine-resistant HR+/HER2− metastatic breast cancer. The findings are based on data from the Phase III GEICAM/2013-02 PEARL trial, which evaluated 555 patients randomized to receive either endocrine therapy plus palbociclib or capecitabine chemotherapy. The study demonstrated that changes in thymidine kinase activity (TKa) may provide an early functional signal of how tumors respond to therapy, supporting the growing role of blood-based monitoring technologies in precision oncology.
DiviTum TKa Captures Distinct Therapy Responses
Researchers reported that TKa levels behaved differently depending on the treatment mechanism, suggesting the assay can capture real-time biological treatment effects. Patients who benefited from capecitabine chemotherapy showed increased TKa activity, while patients responding to CDK4/6 inhibitor-based therapy experienced rapid TKa suppression shortly after treatment initiation. According to the study, these measurable changes were detected within approximately 15 days, potentially allowing clinicians to evaluate therapy effectiveness far earlier than conventional imaging methods. The findings indicate that DiviTum TKa could help physicians better understand tumor proliferation dynamics and personalize treatment strategies in metastatic breast cancer.
Functional Biomarker May Complement Genomic Testing
The study authors emphasized that DiviTum TKa provides different biological information than circulating tumor DNA (ctDNA) testing, which primarily focuses on tumor mutations and genomic evolution. While ctDNA helps identify the genetic characteristics of cancer, TKa measures the tumor’s real-time biological activity and proliferation during treatment. Researchers noted that this functional insight may complement genomic approaches by showing whether a therapy is actively controlling tumor growth. The combination of genomic and functional monitoring technologies could become increasingly valuable as oncology continues moving toward adaptive and personalized treatment models.
Advertisement
Biovica Expands Precision Oncology Monitoring Strategy
Dr. Ángel Guerrero Zotano, a member of the GEICAM Board of Directors involved in the study, stated that TKa is a robust blood-based biomarker capable of monitoring tumor activity in real time and predicting patient response early during therapy. Biovica CEO Theis Kipling added that the assay’s ability to differentiate biological responses across therapies gives clinicians actionable information that traditional genomic tools alone cannot provide. The company believes the latest findings strengthen the clinical positioning of DiviTum TKa as an important component of next-generation cancer monitoring technologies. As precision medicine adoption continues to expand globally, Biovica aims to further establish DiviTum TKa as a valuable tool for treatment optimization and personalized cancer care.
Source: Biovica press release
