TEST:

DiviTum® TKa test

''Biovica...today announced an expansion of an existing Pharma Services work order from a clinical-stage biopharmaceutical company developing a next-generation CDK inhibitor for solid tumors. The expanded work order amounts to approximately USD 75,000 (SEK 700,000). The company has previously engaged Biovica in multiple projects related to its leading oncology program, and the current expansion represents the fourth work order between the parties, reflecting continued expansion of the collaboration. The expanded collaboration was initiated following promising initial TKa biomarker findings generated within the ongoing Phase I program, which led to broader integration of longitudinal TKa testing to further evaluate biological drug activity and proliferation dynamics during treatment. DiviTum® TKa has also been used within the partner’s IND-enabling development activities as part of the translational biomarker package supporting the program’s...

''Biovica,..today announced new data published in the European Journal of Cancer showing that DiviTumTKa can capture early, treatment-specific biological response in patients with endocrine-resistant HR+/HER2− metastatic breast cancer.The analysis included 555 patients from the phase III GEICAM/2013-02 PEARL trial and used Biovica's FDA 510(k)-cleared DiviTum TKa assay. Patients were randomized to receive either targeted therapy (ET + palbociclib) or chemotherapy (capecitabine).''

This multi-biomarker panel was independently associated with poor OS in ICI-treated melanoma patients. This finding suggests a prognostic value of the panel, indicating its potential relevance for stratifying patients by risk, although further validation in larger cohorts is warranted.

''Biovica...today announces two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting. The studies expand the evidence for circulating thymidine kinase activity (TKa), measured with Biovica’s DiviTum® TKa assay, as a pharmacodynamic biomarker in oncology drug development.''

"Biovica...today announces that results from the prospective PDM‑MBC (Personalised Disease Monitoring in Metastatic Breast Cancer) study have been published in Breast Cancer Research and Treatment. The results show that DiviTum® TKa provides robust prognostic information on both progression‑free and overall survival across several early time points. The findings also indicate that thymidine kinase 1 activity (TKa) acts as a continuous marker of risk, supporting more refined modelling approaches for personalized monitoring assessment."

''Biovica...today announced that DiviTum TKa data from the Ciclib trial at Roswell Park have been published in JCO Precision Oncology. Results show that thymidine kinase activity (TKa) measured in blood can predict and dynamically track which patients respond to CDK4/6 inhibitor therapy in HR+/HER2‑ breast cancer.''

''Biovica...today announced that the company has entered into a commercial agreement (client bill agreement) with a leading U.S. NCI-designated Comprehensive Cancer Center. The agreement enables clinicians at the institution to order DiviTum® TKa, Biovica’s FDA-cleared blood-based biomarker test, for clinical use in breast cancer.''

''Biovica...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.''

P=N/A, N=34, Completed, Yale University | Recruiting --> Completed | N=50 --> 34 | Trial completion date: Jan 2028 --> Sep 2025 | Trial primary completion date: Jan 2026 --> Sep 2025

"Biovica...today announces the launch of DiviTum Tka for use in early breast cancer for patients undergoing adjuvant therapy, available as a laboratory developed test (LDT) from its CLIA-certified laboratory in the US. The launch opens a new market indication, representing a potential fivefold expansion of the addressable market for DiviTum TKa."

"Biovica has signed a framework agreement and an initial work order of approximately SEK 0,8 million with an American Tier-1 biopharma company, the fifth in the US. The agreement concerns DiviTum TKa-testing in a Phase I study for next-generation CDK4/6 inhibitors"

P=N/A, N=50, Recruiting, Yale University | Trial completion date: May 2027 --> Jan 2028 | Trial primary completion date: May 2025 --> Jan 2026