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

Projektinformationen

MIRCAB

ID Finanzhilfevereinbarung: 663062

DOI

10.3030/663062

Projekt abgeschlossen

EK-Unterschriftsdatum 13 Januar 2015

Startdatum 1 Januar 2015

Enddatum 30 Juni 2015

Finanziert unter

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

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

MULTIPLICOM NV
Belgium

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

Berichtszeitraum: 2015-01-01 bis 2015-06-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

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.

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

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.

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)

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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