Clinical validation of the DiviTum assay in key European markets

Projektinformationen

CVDTEU

ID Finanzhilfevereinbarung: 650759

DOI

10.3030/650759

Projekt abgeschlossen

EK-Unterschriftsdatum 7 Oktober 2014

Startdatum 1 November 2014

Enddatum 28 Februar 2015

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

BIOVICA INTERNATIONAL AB
Sweden

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

Berichtszeitraum: 2014-11-01 bis 2015-02-28

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

The objective of this SME instrument phase I project was to conduct a comprehensive feasibility study for Biovica’s state-of-the-art assay Divitum™. Divitum™ 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.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

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 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.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

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 €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.

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