MAINTRAC-Auto: Automatization and validation of a liquid biopsy assay “Maintrac-AUTO CTC-analyser” for predictive real time monitoring and success control of solid tumor cancer therapy

Project Information

MAINTRAC-Auto

Grant agreement ID: 717578

DOI

10.3030/717578

Project closed

EC signature date 12 February 2016

Start date 1 March 2016

End date 31 August 2016

Funded under

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

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

SIMFO SPEZIELLE IMMUNOLOGIE FORSCHUNG UND ENTWICKLUNG GMBH
Germany

Periodic Reporting for period 1 - MAINTRAC-Auto (MAINTRAC-Auto: Automatization and validation of a liquid biopsy assay “Maintrac-AUTO CTC-analyser” for predictive real time monitoring and success control of solid tumor cancer therapy)

Reporting period: 2016-03-01 to 2016-08-31

Summary of the context and overall objectives of the project

Circulating tumour cells (CTCs) in cancer patient’s blood serve as accurate biomarkers and liquid biopsy approach. CTCs have been very much acknowledged in the scientific and clinical community, especially as robust independent prognostic factors of progression free and overall survival in patients. At SIMFO GmbH, proprietary maintrac-CTC assays have been developed as innovative technology to detect CTCs very early, even in primary cancer patients, and with high sensitivity compared to other diagnostic tools. Thus CTCs are used as sensitive markers to initiate treatments adequately to patient’s progression of disease and to replace ineffective treatments. After cancer remission, CTC counts are used for long-term monitoring to identify potential relapse for immediate treatment. Until today maintrac CTC-assays has achieved clinical proof in more than 650 patients analysed in 13 clinical trials. Our overall objective of the SME innovation project is to achieve series-production readiness of a fully automated CTC-analyser maintrac-AUTO and to launch the system commercially.

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

Using SME Phase 1, SIMFO targeted several objectives to evaluate the feasibility of our project. The CTC-analyser maintrac-AUTO was run with several stress tests and long-time tests to proof assay stability under different conditions and achieved stable and reliable outcomes. The process to qualify for CE Certification in concordance to EG98/79 has been started. In parallel SIMFO is aiming to broaden the acceptance by national and international oncology specialists through in depth clinical validation. In the long term, SIMFO aims to achieve public reimbursement to realize upscaling and broad market penetration.

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)

However, CTC assessment has considerable challenges. Capture and identification of these very rare cells depends very much on the used technique. Clinical trials proofed that maintrac finds clinically relevant cells even in primary cancer patients; other methods concerning CTCs or liquid biopsy techniques lack this long time data. In addition, high throughput assays are not available. Therefore SIMFO GmbH has developed the first high-throughput analyser for CTC biomarker analyses which allows processing of ca. 400 patient samples per day with an excellent specificity and sensitivity profile not yet achieved so far by other competing CTC systems.
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