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

Project Information

MIRCAB

Grant agreement ID: 663062

DOI

10.3030/663062

Project closed

EC signature date 13 January 2015

Start date 1 January 2015

End date 30 June 2015

Funded under

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

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

MULTIPLICOM NV
Belgium

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

Reporting period: 2015-01-01 to 2015-06-30

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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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