Integrated and standardized ngs workflows for personalised therapy
Instand-NGS4P is a 60-month PCP project federating 7 leading medical centers (two are coordinating ERNs) as buyers’ group with major experience in using different NGS platforms in research and routine diagnostics. The consortium is further strengthened by European patient advocacy groups, a standardization organization and partners participating in the European infrastructures BBMRI-ERIC, ELIXIR as well as several NGS-related EU programs to cover all technical aspects and transversal needs & requirements. Driven by patient and clinical needs, innovative NGS workflows from sample-pre-analytics to medical decision making will be developed. The modular design of the workflow will particularly enable SEMs to contribute, and provides flexibility to adopt emerging user needs and technologies. Specifications will address regulatory requirements for IVDs and refer to international standards and requests development of reference materials and implementation of EQA schemes covering the whole workflow. R&D suppliers will be selected based on a public tender all along this PCP process in 3 phases according to the best-value for money solution. The 3 phases foresee the leverage of 4 technical modules (pre-analytics, sequencing, bioinformatics, e-reporting/e-medication) and their standardized interfaces – from design (Phase 1) to prototypes (Phase 2), and full integration in Phase 3. At the end, this PCP will provide 2 fully integrated, standardized NGS workflows for routine diagnostics of common and rare cancers from adults to children. In order to enable broad implementation in healthcare systems throughout Europe and beyond and to increase benefit to patients a series of support activities are planned including communication and dissemination activities targeting a broad stakeholder community, development of training and education material for healthcare professionals and patients, health economic assessment and engagement with healthcare payers and policy makers.