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New publication strengthens the case for DiviTum TKa in early treatment assessment

BIOVIC BRegulatoriskt pressmeddelande2026-08-04 09:00
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Biovica, a company specializing in blood-based cancer monitoring, today announced that new results involving DiviTum® TKa have been published in the peer-reviewed journal Clinical Cancer Research.

The study evaluated a new treatment combination for patients with advanced breast cancer whose disease had progressed after previous CDK4/6 inhibitor treatment. The combination included avutometinib, a drug targeting a pathway linked to resistance to CDK4/6 inhibitors, together with abemaciclib and fulvestrant.

Importantly, all patients who experienced clinical benefit had low TKa levels early during treatment, while higher levels were seen in patients who did not benefit.

These findings support the potential of DiviTum TKa to identify treatment benefit early, an important step toward its future use in treatment decisions and clinical drug development.

“This publication provides a clear example of how DiviTum TKa may offer clinically relevant information early during treatment. For Biovica, the results strengthen the scientific foundation for expanding the use of DiviTum TKa across new treatment classes and clinical studies, while further supporting the relevance of our Pharma Services offering” said Theis Kipling, CEO of Biovica.

The study included 16 patients, and the TKa results were exploratory. An ongoing Phase II study will further evaluate TKa alongside other biomarkers, providing an opportunity to validate and build on these results.

The article, titled Avutometinib, Abemaciclib, and Fulvestrant in Patients with HR+/HER2- Metastatic Breast Cancer Previously Treated with CDK4/6 Inhibitor: A Single-Arm Phase I Trial, was published in Clinical Cancer Research.

Contact


Theis Kipling, CEO
Telefon: +46 (0) 76 666 36 52
E-post: theis.kipling@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

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New publication strengthens the case for DiviTum TKa in early treatment assessment