Presentation

Company Profile
Biovica develops and commercializes blood-based biomarker assays for evaluating the effect of cancer treatments. DiviTum® measures thymidine kinase activity (TKA), which indicates the cell proliferation rate and clinical studies have shown that it can quickly reveal whether treatment is effective. DiviTum® has the potential to reduce cost and to improve cancer care by monitoring treatment and provide information for better treatment decisions. Research and development, production facilities and the head office are in Uppsala, Sweden. The current customers comprise of pharmaceutical companies and CROs (Contract Research Organizations). Biovica’s strategy is to establish DiviTum® in the much larger clinical oncology market, starting within breast cancer settings.

Recent highlights
Biovica has submitted its 510(k) application to the FDA to gain market approval. Due to COVID-19, the FDA had de-prioritized Biovica’s application, leading to a nearly six months delay. Then the FDA resumed its review and got back to Biovica with technical questions which we expect to be fully answered and solved by latest September.

Outlook
Biovica’s DiviTum® is approaching market launch within monitoring of CDK4/6 inhibitor treated metastatic breast cancer patients The US market approval is expected. DiviTum® will first be launched in the United States, followed by Europe's five largest markets and the Nordic region. More long term Biovica aims to establish DiviTum® in additional markets and for the treatment of more types of cancer and new targeted therapies.