Under the agreement, Biovica will provide TKa testing across multiple projects using its DiviTum® TKa assay, along with its expertise in interpreting TKa measurement dynamics to support drug development. As part of the agreement, the first work order has already been signed and pertains to a large-scale clinical trial in breast cancer. The total expected revenue from the first work order amounts to SEK 4 million.

“This marks an important milestone in the continued adoption of our DiviTum TKa assay. This collaboration is our 17th broader collaboration agreement (MSA) with a pharmaceutical partner and our fourth with a Tier-1 oncology company. The agreement not only validates the clinical relevance of our TKa biomarker but also strengthens our position to co-develop a future Companion Diagnostic (CDx) product—ultimately benefiting cancer patients undergoing treatment,” said Anders Rylander, CEO of Biovica.

This collaboration will broaden the application of DiviTum TKa in clinical trials focused on next-generation oncology therapies, further strengthening the potential for TKa to be established as a key biomarker for therapeutic monitoring. The study is a Phase Ib/II multicenter, open-label, randomized trial. The trial focuses on patients with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer, with a total enrollment of 250 patients.

Biovica will conduct all TKa testing at its U.S. laboratory, with testing services commencing early September 2025, and continuing through December 2028.