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OBJECTIVES

Developing and Implementing ISO and CEN Standards as well as pan-European Quality Assurance (EQA) Schemes
 

The first SPIDIA project (2008 - 2013) within in the EU 7th Framework Programme determined the important influencing pre-ana­lytical workflow factors in regards to blood, plasma, urine and tissue samples.

These studies laid the basis for the development and implementation of the first 9 CEN Technical Specifications (CEN/TS) for pre-analytical workflows.

Under the Vienna Agreement, these new CEN/Technical Specification (CEN/TS) documents were also presented to the International Organization for Standardization’s Technical Committee 212 for “Clinical laboratory testing and in vitro diagnostic test systems” (ISO/TC 212).

At the ISO/TC 212 until now 7 out of these 9 CEN/TS were further developed to ISO/ International Standards which is the next big step towards the improvement of worldwide healthcare systems.
These ISO standards have meanwhile substituted the former CEN/TS in Europe. They have reached global recognition successfully and are now available in Europe as EN ISO-series 20166, Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue, EN ISO-series 20184, Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue and EN ISO-Series 20186, Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood.

Building on the big international success of the SPIDIA project, the new project SPIDIA4P (SPIDIA for Personalized Medicine) within the EU Horizon H2020-SC1-2016-107 programme, has started on January 1, 2017:

SPIDIA4P has meanwhile initiated to develop and implement 14 pan-European pre-analytical CEN/TS and ISO/ IS documents via the CEN/TC 140 "In vitro diagnostic medical devices". These will address the important pre-analytical workflows applied to personalized medicine and are planned to be also applicable to biomarker discovery, development and validation as well as to biobanks providing human specimens and human derived materials used for research.

In July 2018, the first CEN/TS initiated by SPIDIA4P has been published:

CEN/TS 16826-3:2018 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA

Once finished, these additional documents will complement the existing standard documents initiated by SPIDIA, aiming to create and implement a comprehensive portfolio of in total 22 pre-analytical CEN/ Technical Specifications and ISO/ International Standards, addressing the important pre-analytical workflows applied to personalized medicine.

Altogether, the highly experiences project partners, consisting of key experts of 19 stakeholder organizations in coordination action with other large initiatives and major stakeholder organisations, plan to develop the following high priority pre-analytical CEN and ISO standard documents as well as corresponding EQA schemes and implementation tools.

12 PLANNED OR MEANWHILE EXECUTED NEW PAN-EUROPEAN PRE-ANALYTICAL CEN TECHNICAL SPECIFICATIONS

•  3 new pre-analytical CEN/technical specification documents for in venous whole blood circulating tumour and organ cells (DNA, RNA, staining procedures)

•  1 for venous whole blood exosomes

•  1 for venous whole blood cell free circulating RNA

•  1 for saliva (DNA)- published

•  1 for frozen tissues (DNA) - published

•  1 for urine and other body fluids (cell-free DNA)

•  3 for fine needle aspirates (RNA, DNA, Proteins)

•  1 for human specimen microbiome (DNA)

2 PLANNED NEW INTERNATIONAL PRE-ANALYTICAL ISO STANDARDS

•  1 for FFPE Tissues (in-situ staining procedures)

•  1 for Metabolomics (urine, blood plasma, blood serum)

13 PLANNED NEW  EXTERNAL QUALITY ASSURANCE  SCHEMES

•  Venous Whole Blood: Genomic DNA and cellular RNA, viable PBMC, Cell Free Circulating DNA (ccfDNA), Cell Free Circulating RNA (ccfRNA), Circulating Tumour Cells (CTCs)

•  FFPE tissue: Genomic DNA, RNA, protein

•  Frozen tissue: Genomic DNA, RNA, protein

•  Saliva: DNA

•  Stool: DNA