- Establish a quality management system for NGS-based clinical assays
- Standardize assay-reporting outcomes
- Develop recommendations, guidelines, and best practices
- Perform Experimental Quality assurance (QA) studies based on expertise from ELBS consortium
This working package is focusing on implementation of NGS-based and liquid biopsy assays in clinical practice. Our aims are establishing a quality management system for NGS-based clinical assays and standardizing assay-reporting outcomes to facilitate data harmonization across the EU. We will develop recommendations, guidelines, and best practices to move the clinical implementation of NGS technologies forward and perform experimental quality assurance based on expertise from ELBS consortium.
Our main goals are to define standards and quality metric for NGS, develop a framework for phenotypic and clinical data from patients to make genetic data useful in clinical settings, and to develop a framework that facilitates interoperability across the national genomic, clinical, and phenotypic data to detect best practices in sharing and linking the data. We aim to develop external quality standards and carry out technical validation of liquid biopsy assays for solid tumours and hematologic malignancies, as well as create a framework for the establishment of a permanent organization for maintenance of a recurrent liquid biopsy QA program and certification.