Quality assurance

How reliable is the Mark53® analysis?

Globally, the most diverse p53 tests are currently being offered. These deliver completely inconsistent results, which are primarily due to the methodology being used. Until now, a precise, standardised p53 test has not been available for clinical application. The Mark53® analysis is a standardised p53 gene test, which has been designed for routine clinical application and has also been clinically tested. A special procedure (gene-specific sequencing) enables a high degree of sensitivity and specificity in the recognition of mutations of the p53 gene. This procedure also enables a drastic reduction of work effort, which – in turn – contributes to the security of the results.

Quality assurance

Precision of the gene analysis: The method of gene-specific sequencing, which has been specially developed for the Mark53® analysis, minimises possible sources of error within the context of the gene sequencing. Security of the results: The Mark53® analysis comprises a triple analysis and therewith also a triple evaluation, whereby an error becomes highly unlikely. Interpretation security: The impact of the TP53 genotype on the response to chemotherapy has hitherto been tested and proven in clinical studies on more than 1,000 cancer patients. In ongoing clinical studies, new substances and cancer types are continuously being incorporated and therewith the knowledge for substance recommendation is constantly being expanded.