Projects funded through European Regional Development Fund (ERDF)

The aim of the project is to research and produce certified reference materials for molecular diagnostics to enable diagnostics according to recognised guidelines (e.g. IVDR). To this end, procedures are being researched in collaboration with the University of Greifswald in order to be able to examine these reference materials in a proof of concept study.

SensID GmbH specialises in the development, production and marketing of reference material for DNA diagnostics. The resulting products are used in the areas of research and development, pathology, prenatal diagnostics, forensics, instrument validation, training of personnel, interlaboratory tests, diagnostic test validations and other areas of application.

SensID aims to provide its customers with certified reference materials for clinical diagnostics. SensID has been working successfully in this field with a focus on DNA-based control material since the start of work in the laboratories. In addition to the common use of DNA-based tests for molecular diagnostics, the field of RNA-based diagnostics using NGS (Next Generation Sequencing) technology is emerging.

For this reason, the aim of this project is to research, develop and test possibilities for the production of certified reference materials on the basis of ribonucleic acid (RNA) for RNA sequencing procedures and other initially primarily RNA-based NGS applications within the framework of a cooperation with the University of Greifswald, Prof Kuss (AG Molekulare Humangenetik). Within the scope of these diagnostics, gene fusions are investigated at the RNA level. Such gene fusions are hybrid genes that arise from the breakage and reunion of two different chromosomes or from intra-chromosomal rearrangements through deletions, insertions or inversions and are often oncogenic in the process.

The feasibility study deals with the research and development of a suitable blood matrix as a basic control material for molecular in vitro diagnostics. The analysis of genetic cancer mutations has also become enormously important for patient management and treatment decisions. The evaluation of the mutation profile in the context of a patient's cancer is mostly done by using genetic tests. The determination of cell-free DNA (cfDNA) and RNA (cfRNA), circulating tumour cells (CTC) and extracellular vesicles (EV) in blood or other body fluids, for example, enables early cancer detection, assessment of tumour dynamics, detection of minimal residual disease and therapy monitoring.
The aim of the implementation study is to research and develop a suitable blood matrix as a basic control material for molecular in vitro diagnostics.