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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 2 - SPIDIA4P (SPIDIA for Personalized Medicine - Standardisation of generic Pre-analytical procedures for In-vitro DIAgnostics for Personalized Medicine)

Reporting period: 2018-07-01 to 2019-12-31

Started on January 1st, 2017, the goal of the 48-month project SPIDIA4P is 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. These CEN/TS and ISO/IS will also be applicable laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. The standard documents are thus applicable to all segments and the entire value chain which contribute to biomarker discovery, development and implementation into healthcare: high quality samples in biobanks as the decisive basis for all biomarker related work, biomedical research in the industry and other research institutions to develop biomarkers including generation of scientific evidence for these, in-vitro diagnostic (IVD) test development, and implementation and use of these IVD tests in healthcare systems. Furthermore, corresponding External Quality Assurance (EQA) Schemes will be developed and implemented by SPIDIA4P as well, aiming to survey the resulting diagnostic practice.
During the first 36 project months, SPIDIA4P progressed the project work for all intended new CEN/TS and ISO/IS documents. This work is happening at the CEN/Technical Committee (CEN/TS) 140 for “In vitro diagnostic medical devices” and at the ISO/TC 212 for “Clinical laboratory testing and in vitro diagnostic test systems”. All voting / ballots via the European (CEN) or global National Standards Bodies (ISO) resulted in a strong support for all these new documents.
A huge success in late 2018 and during the course of 2019 was the finalization and publication of the first 8 ISO International Standards for molecular diagnostic preanalytical workflows: Molecular in vitro diagnostic examinations — Specifications for pre-examination processes.
In Europe these new documents replaced as EN ISO Standards the former CEN/TS documents, which were originally initiated by SPIDIA and had been introduced in Europe in 2015.

This success was enhanced by the publication of new CEN/TS standard documents in 2019 or by finalization for publication in early 2020:
- Molecular in vitro diagnostic examinations — Specifications for pre-examination processes.
The Saliva DNA and the Frozen Tissue DNA documents have meanwhile become also projects at the ISO/TC 212 for progressing them further to ISO Standards under the Vienna Agreement.
All other planned new CEN/TS documents have become approved and running projects at the CEN/TC 140:
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes.
Two additional SPIDIA4P initiated new ISO/IS documents are also meanwhile progressed projects at the ISO/TC 212:
- Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for
- Metabolomics in urine, venous blood serum and plasma
- Formalin-fixed and paraffin-embedded (FFPE) tissue -Part 4: in situ detection techniques
SPIDIA4P has until now also develop the majority of the intended EQA Schemes, corresponding to the already published ISO and CEN documents and to the new upcoming SPIDIA4P CEN and ISO documents, aiming to survey the resulting diagnostic practice. During the first 36 project months, the 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).
SPIDIA4P has run a quite huge portfolio of measures for the implementation and dissemination of standards and EQA Schemes.
Furthermore SPIDIA4P become linked to two additional new HORIZON 2020 projects in 2019: EASI-Genomics (https://www.easi-genomics.eu/home) and EU-STANDS4PM (https://www.eu-stands4pm.eu/). The already established close co-work with other consortia successfully continued, such as with CANCER-ID (https://www.cancer-id.eu until December 2019), CBmed (www.cbmed.at) and several others.
The SPIDIA4P funding period will end by December 2020. SPIDA4P is on a very good track to have by then generated and implemented the comprehensive portfolio of 22 pre-analytical CEN/TS and ISO/IS documents as listed above, addressing the important pre-analytical workflows applied to Personalised Medicine. Corresponding EQA Schemes will have been developed and implemented as well, aiming to survey the resulting quality of samples and diagnostic practice.
Diagnostic errors cause about 10% of all patient deaths and about 17% of adverse events [Institute of Medicine (IOM) Report Sept. 2015]. Based on SPIDIA’s and meanwhile also other consortia’s broad evidence, it is expected that these CEN/TS and ISO/IS documents and their associated EQA Schemes wil significantly contribute to the sustainability of health care systems by reducing the number of diagnostic errors. The standards are of key importance as pre-analytical workflows contribute by about 50 – 70% to the laboratory diagnostic errors rate [e.g. Medical Laboratory Observer; May 2014]. Securing good quality clinical samples with molecular bioanalyte profiles as they were in the patient’s body, is decisive for most of the applications in Personalized Medicine.
SPIDIA4P’s work has become also important in light of the new EU “in vitro diagnostic medical devices regulation (IVDR)” which was released in May 2017 with a 5 year’ transition period (REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL). This new law contains in several paragraphs dedicated requirements for analytical test relevant pre-analytical workflow variables. The CEN/TS and ISO/IS documents are in line with these requirements of the regulation. It is therefore expected that the standards as well as the EQA Schemes will become quite relevant for translating these IVDR requirements into daily routine. SPIDIA4P authors have published a dedicated paper on this topic (https://www.sciencedirect.com/science/article/abs/pii/S1871678419300822?dgcid=coauthor).
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. This will lead to faster growth and benefits to the European diagnostics industry, also to SMEs working on new biomarkers and new services.
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