Instand-NGS4P is a 54-month PCP project federating 7 leading medical centers as buyers’ group as experts in different NGS platforms in research and routine diagnostics. The consortium is strengthened by European patient advocacy groups, a standardization organization and partners participating in the European infrastructures BBMRI-ERIC, ELIXIR to cover all technical aspects, needs & requirements. Driven by patient and clinical needs, innovative NGS workflows from sample-pre-analytics to medical decision making are developed. The modular design of the workflow will particularly enable SEMs to contribute, and provides flexibility to adopt emerging user needs and technologies. Specifications address regulatory requirements for IVDs and refer to international standards and requests development of reference materials for EQA covering the whole workflow. R&D suppliers are selected based on a public tender all along this PCP process in 3 phases according to the best solution. The 3 phases foresee 4 technical modules and their standardized interfaces – from design (Phase 1) to prototypes (Phase 2), and integration in Phase 3. At the end, this PCP provides 2 fully integrated, standardized NGS workflows for routine cancers. In order to enable broad implementation and to increase benefit to patients a series of support activities are planned.
The development of IVD approved equipment and tools for the NGS workflow is under the IVD-R a must for the diagnostic laboratories not allowed to perform LDT’s and must use tests supplied by a manufacturer. This way the diagnostic laboratories can run the NGS diagnostic tests more reproducible and reliable.