UPPSALA, SE / ACCESS Newswire / May 19, 2025 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Biovica, a leader in blood-based cancer monitoring, today announces the signing of a Master Service Agreement (MSA) with a US-based pharmaceutical and biotechnology company recognized as a Tier-1 player in oncology. A first work order has also been signed totaling SEK 4 million.
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.
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
SOURCE: Biovica International
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