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SPIDIA for Personalized Medicine - Standardisation of generic Pre-analytical procedures for In-vitro DIAgnostics for Personalized Medicine

Periodic Reporting for period 3 - SPIDIA4P (SPIDIA for Personalized Medicine - Standardisation of generic Pre-analytical procedures for In-vitro DIAgnostics for Personalized Medicine)

Reporting period: 2020-01-01 to 2021-06-30

Started on January 1st, 2017, the of SPIDIA4P was to go the next steps towards healthcare systems improvements with worldwide impact by developing and implementing a comprehensive portfolio of 22 European pre-analytical CEN/Technical Specifications (CEN/TS) and ISO/International Standards (ISO/IS), addressing the important pre-analytical workflows applied to personalised medicine in medical laboratories.
SPIDIA4P achieved its goals for all intended new CEN/TS and ISO/IS documents. SPIDIA4P is fully on track to have the comprehensive portfolio of 22 new pre-analytical CEN and ISO documents developed via the CEN/Technical Committee 140 “In vitro diagnostic medical devices” and the ISO/Technical Committee 212 “Clinical laboratory testing and in vitro diagnostic test systems. Until now 11 new ISO International Standards and 5 new CEN/Technical Specifications are available in the Global (ISO) and / or European market (ISO, CEN). It is expected that also these documents will become available until end of 2021 or early 2022. 16 ISO and CEN standards are introduced and available. The ones for this period are: Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for: Formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)/ Frozen tissue – Part 3: Isolated DNA (ISO 20184-3:2021)/ Metabolomics in urine, venous blood serum and plasma (ISO 23118:2021)/ Circulating tumor cells (CTCs) in venous whole blood – Part 1: Isolated RNA (CEN/TS 17390-1:2020) /Circulating tumor cells (CTCs) in venous whole blood – Part 2: Isolated DNA (CEN/TS17390-2:2020)/Circulating tumor cells (CTCs) in venous whole blood – Part 3: Preparations for analytical CTC staining (CEN/TS 17390-3:2020)/Saliva – Isolated human DNA (CEN/TS 17305:2019)/Human specimen – Isolated microbiome DNA (CEN/TS 17626:2021).
This success will be enhanced by the upcoming publications of following new CEN/TS standard documents which are all accepted for their final voting / ballot via the European National Standard Institutes:: the ones for this period are:Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for: Fine Needle Aspirates (FNAs) – Part 1: Isolated cellular RNA (FprCEN/TS 17688-1)/ Fine Needle Aspirates (FNAs) – Part 2: Isolated proteins (FprCEN/TS 17688-2)/Fine Needle Aspirates (FNAs) – Part 3: Isolated genomic DNA (FprCEN/TS 17688-3)/Venous whole blood – Isolated circulating cell free RNA from plasma (prCEN/TS 17742)/Exosomes and other extracellular vesicles in venous whole blood – Isolated RNA, DNA and proteins (prCEN/TS 17747)/Urine and other body fluids – Isolated cell free DNA (no number yet). As targeted in the SPIDIA4P program, the three Circulating tumor cells (CTCs) and the Saliva DNA documents have meanwhile become also projects at the ISO/TC 212 for progressing them further to ISO Standards under the Vienna Agreement between CEN and ISO. The Saliva DNA document has even just finalized its final international ballot as “Final Draft International Standard (FDIS)”. SPIDIA4P project it became more and more obvious that the new pre-analytical ISO and CEN standards also play a key role in fulfilling the preanalytical and related state-of-the-art requirements as well as scientific validity requirements in the new “EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). Accreditation and certification programs at most SPIDIA4P consortium members and implementations of the pre-analytical ISO and CEN standards generated role examples how this can be achieved and improves in vitro diagnostic product developments as well as diagnostic services.SPIDIA4P has also developed the intended EQA Schemes, corresponding to the ISO and CEN documents, aiming to survey the resulting diagnostic practice. In total 13 EQA Schemes were finally tested by SPIDIA4P consortium and partner consortia participants, published and implemented into the public available proficiency testing programme of the SPIDIA4P partner Integrated BioBank of Luxembourg (IBBL). During the last period of SPIDIA4P a deep and broad statistical analysis of the IBBL proficiency testing participants’ results over several years was performed. Different quality metrices, such as nucleic acids yields, purity, integrity were evaluated. The results confirmed pre-analytical workflow variables and parameters addressed in the ISO and CEN standards but also delivered input for the first revisions of the standards coming up in 2-4 years. A scientific paper is submitted: “External Quality Assurance programs for processing methods provide evidence on impact of preanalytical variables”, Clin Chem Lab Med.SPIDIA4P has run a quite huge portfolio of measures for the implementation and dissemination of standards and EQA Schemes. More details can be found on the SPIDIA4P website (www.spidia.eu). Furthermore SPIDIA4P became linked to one additional new HORIZON 2020 projects in 2020: a Translational Access (TNA) project within ERINHA, the European Research Infrastructure on Highly Pathogenic Agents. The already established close co-work with other consortia successfully continued, such as with EASI-Genomics (https://www.easi-genomics.eu/home) EU-STANDS4PM (https://www.eu-stands4pm.eu/) INSTAND-NGS4P (https://www.instandngs4p.eu/) CBmed (www.cbmed.at) CD-Laboratory on Liquid Biopsies in Graz/Austria and several others.Furthermore in 2020 the ISO/TC 212 ““Clinical laboratory testing and in vitro diagnostic test systems” and the ISO/TC 276 “Biotechnology” decided to build a new ISO Joint Working Group (JWG) for developing an ISO/Technical Specification for SARS-CoV-2 RNA based test developments. This project is generating a quite huge interest over the world.
As described above, SPIDA4P has achieved its goal to generate a portfolio of 22 pre-analytical CEN/TS and ISO/IS documents addressing the important pre-analytical workflows applied to Personalised Medicine and to drive the implementation of these in healthcare, biomedical research and biobanking. Corresponding EQA Scheme have been developed and implemented as well, aiming to survey the resulting quality of samples and diagnostic practice.
As the CEN/TS and ISO/IS documents are also applicable to research and biobanks, it can be expected that the too high percentage of non-reproducible research studies will be reduced. An increasing number of scientific publications are citing the new pre-analytical ISO and CEN standards.Overall this will lead to faster growth and benefits to the European diagnostics industry, also to SMEs working on new biomarkers and new services.
The development of the significant portfolio of International and European Standards and their impact on European research, diagnostics and innovation was recognized by European awards and the selection of SPIDIA4P by the European Commission as a success story project: 2016: DIN Award on Use of Standards (Berlin)-SPIDIA success / 2017: Golden Honary Needle DIN (Stockholm)-SPIDIA4P success/ 2020: CEN & CENELEC Standard and Innovation Award (Brussels)-SPIDIA4P success/ 2020: SPIDIA4P selected by the European Commission as one of three success stories showcased in the Standardization Fact Sheet published at the World Standards Day 2020.
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