Periodic Reporting for period 1 - CVDTEU (Clinical validation of the DiviTum assay in key European markets)
Periodo di rendicontazione: 2014-11-01 al 2015-02-28
The objective of the feasibility study was to identify and analyze key European markets and to identify and approach key stakeholders and partners with whom to perform clinical validation studies. In addition the objective was to define detailed protocols and budgets for the said clinical studies.
1. Identification and analysis of key European markets
2. Identification and approach of potential partners
3. Design and outline clinical studies (including protocols)
All objectives of the feasibility study were reached during the project. The study resulted in established contacts with several KOLs in Europe, in addition to a validated market interest for the assay and a validated business model. The feasibility study also provided input to update Biovica’s business plan. The final outcome of the action are two agreements for initiation of clinical trials to validate Divitum for predicting, monitoring and evaluating the effect of cell cycle dependent drugs in advanced solid tumors.
Being able to predict which patients will respond to treatment and to monitor the effect of treatment yields benefits for patients, healthcare systems and drug developers. Novel cancer treatments are highly selective and costly, thus it is crucial for the healthcare system to be able to select the patients that will actually respond to the treatment. Furthermore, patients are ensured that the cytotoxic treatment they receive, with guaranteed side effects, will be effective.
We estimate that we will increase our turnover to €30 million (560%) and our head count to 40 FTE (700 %) 3 years following the implementation of the action. This will be the result of a broad market introduction made possible after the relevant clinical validation of the biomarker assay together with highly impactful partners.