Reference Measurement Systems to support validation and quality assurance of genomic profiling IVDs

Aims

• to implement genomic testing workflows and to evaluate quality assurance/quality control performance metrics reflecting intermediate steps in genomic workflows and their impact on the quality of Next Generation Sequencing data

• to measure assay validation parameters such as qualitative and quantitative accuracy of Next Generation Sequencing output

• to develop recommendations for applying metrological solutions to support clinical laboratory quality assurance in the implementation and maintenance of genomics workflows

• to develop recommendations for the application of metrological solutions to analytical validation of In Vitro Diagnostic Medical Devices and laboratory-developed tests.