Scientific results
The project will provide structured knowledge about the diagnostic and prognostic significance of selected nucleic acid modifications in CLL. The planned scientific results include publications in highly regarded journals and presentations of results at international conferences.
Application and implementation results
The key outcome of the project will be a diagnostic and prognostic panel and related validated analytical (UPLC-MS/MS) and cytometric procedures, developed for implementation in routine diagnostic laboratories. The expected result is to increase the accuracy and speed of diagnostics at an acceptable cost, as well as to improve the monitoring of therapy effects, including the detection of minimal residual disease (MRD).
Quality standards and regulatory compliance
The project takes into account regulatory requirements (in particular IVDR) and emphasizes automation, standardization, and quality control. The developed procedures will include elements necessary for validation: calibration and control protocols, acceptance parameters, a description of pre-analytical and analytical stages, and rules for interpreting results.