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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - CVDTEU (Clinical validation of the DiviTum assay in key European markets)

Teaser

Summary

The objective of this SME instrument phase I project was to conduct a comprehensive feasibility study for Biovicaâ€™s state-of-the-art assay Divitumâ„¢. Divitumâ„¢ is the most sensitive assay for measuring cell proliferation rate and can be used to predict and evaluate the efficacy of cancer therapies.

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.

Work performed

The work performed during the entire action consisted of three main activities:

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 Biovicaâ€™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.

Final results

The overall objective of the project proposed in the application to the SME instrument is the clinical validation of Divitum in order to enable a broad market introduction of the technology.

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 â‚¬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.