- Bundesministerium für Bildung und Forschung (BMBF)
- VDI/VDE Innovation+Technik GmbH Berlin
Individual therapy success and survival rate of tumor patients depend essentially on whether and to what extent tumor cells have detached themselves from the primary tumor, entered the bloodstream (Circulating Tumor Cell = CTC) and have gained the ability to form metastases. In the CTC-Detect project, a device is being developed that can quantify CTCs via label-free detection and additionally measure clinically relevant tumour markers in parallel. With this system, a diagnostic approach is pursued that can detect a risk of metastasis in tumor diseases by non-invasive detection of molecular and cellular markers from patient blood.
The aim of this collaborative project is to develop an automated device (prototype) with breast cancer as a model, which combines (i) the accumulation of circulating tumor cells (CTC) from whole blood and (ii) the subsequent identification of the CTC and phenotyping of the cells with a multi-marker test. Recently presented studies suggest a clinical relevance of the detection of CTC in blood, so that the detection of CTC can become an important pillar in the therapy optimization of primary and metastatic breast cancer. Persistent CTC are suitable surrogate markers for therapy resistance in the adjuvant and metastatic situation and can therefore be used as an indicator for secondary adjuvant therapy or for switching palliative therapy.
For the identification of new tumor markers and the development of new CTC assays it is important to find biomarkers with high specificity. Currently, individual tests are not sufficient for tumor diagnosis and the purity of CTC enrichment is still too low. New, optimized biomarkers can increase the significance of the test and thus considerably reduce the scope of testing.
Within the scope of the research project, antibody-labelled CTCs are to be detected using a label-free detection method. Stratec has access to a novel method for the label-free measurement of immunological tests. As a company with 30 years of experience in the development and production of automated systems in the in vitro diagnostics industry, Stratec has the know-how to further develop the so-called label-free technology into a prototype reader and to transfer this prototype into series production.
The NMI has many years of expertise and an international reputation in the development and application of miniaturized parallel immunoassays for the detection of proteins from small sample quantities using microarrays. The multiplex detection of a large number of proteins from blood and also directly from tumor tissue is used in cooperation with partners from the pharmaceutical industry and hospitals for the identification of early diagnostic and prognostic markers in drug development. In the project, the NMI is developing and optimizing a microarray chip with biochemically structured capture fields to which CTCs from blood can adhere and be quantified. In addition, the NMI is developing a multi-marker test on the adhered cells that can be used to functionally characterize and type CTCs.
The University Women's Hospital (UFK) in Tübingen provides the necessary blood samples for the development and evaluation of the device. The UFK also has the know-how of already available detection methods, such as the CellSearch® system (Veridex, Johnson&Johnson) approved by the American Food and Drug Administration (FDA), with which the performance of our new methods can be compared.
- Stratec Biomedical AG, Birkenfeld (Koordination)
- UFK Universitätsfrauenklinik, Tübingen