Validation of diagnostic and/or prognostic miRNAs in triple-negative breast cancer

Informations projet

MIRCAB

N° de convention de subvention: 663062

DOI

10.3030/663062

Projet clôturé

Date de signature de la CE 13 Janvier 2015

Date de début 1 Janvier 2015

Date de fin 30 Juin 2015

Financé au titre de

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

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

MULTIPLICOM NV
Belgium

Periodic Reporting for period 1 - MIRCAB (Validation of diagnostic and/or prognostic miRNAs in triple-negative breast cancer)

Période du rapport: 2015-01-01 au 2015-06-30

Résumé du contexte et des objectifs généraux du projet

The overall objective of this project was to validate a selected set of miRNAs as diagnostic and/or prognostic markers in triple-negative breast cancer (TNBC) and to develop a multiplexed quantification method for the creation of an innovative test kit. This project addresses the need in personalized healthcare to validate diagnostic tests that can contribute to optimal use of therapeutic options thereby resulting in lower overall healthcare costs and improved quality of life for TNBC patients. A validated test kit has the potential to put Multiplicom ahead of competition in making personalized medicine reality at an affordable cost.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

During the first phase, Multiplicom has extended its network of key opinion leaders (KOLs) from the TNBC field with one additional German partner. In close collaboration with the international KOL network Multiplicom has;
1) Carefully performed a miRNA selection for TNBC based on the KOL’s research experience and literature
2) Initiated the analysis on intellectual properties and freedom-to-operate
3) Investigated the use of an easily accessible miRNA quantification method
4) Assessed the feasibility of an European-wide, multi-center clinical validation study and
5) Performed a market search on TNBC and worked out a competitive strategy
Besides the lack of one single multiplexed miRNA assay platform to minimize inter participant differences, there is at present limited access to TNBC patients with tissue or blood for miRNA profiling. Based on the numbers of clinically validated samples (219 FFPE samples for which RNA was already extracted using different techniques, and 670 samples with tissue for RNA extraction), the power required for a comprehensive study is not sufficient to establish a significant miRNA biomarker signature with an effect size over 2.5 and larger for effective clinical relevance. In addition, the selection of most important miRNAs for TNBC is not straightforward and the extensive IP presence substantially hampers the development of a TNBC miRNA profiling assay with adequate own IP. Based on the abovementioned risks Multiplicom decided not to pursue with the initial project’s idea at this stage.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

In spite of the diagnostic potential of miRNAs in TNBC, the challenges identified for the creation of an innovative miRNA biomarker test which is diagnostic or prognostic for TNBC are not in favor of a successful introduction into the market and translation to clinical practice. In the absence of a suitable multiplexed miRNA assay platform, at this stage Multiplicom has decided to abandon the present business idea.

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