Next-generation sequencing (NGS) has taken modern research by storm and consequently is one of the most important tools of modern biological and biomedical research. However, the high cost of instrumentation and reagents, the multifaceted expertise required for correct use and the legal and ethical issues hamper access to NGS technologies for many researchers. EASI-Genomics addresses those challenges by unifying the major European genome centers that provide external access to their facilities. The mission of EASI-Genomics is to facilitate access to cutting-edge DNA sequencing technologies to researchers from both academia and industry, within a framework that ensures compliance with ethical and legal requirements, as well as FAIR and secure data management. EASI-Genomics will provide fully funded access to more than 150 transnational access projects, selected through public calls and a rigorous, fair and transparent peer-review process. Each funded study will be supported from design, through sequencing, to data analysis. EASI-Genomics will provide more than 100 Tb of sequence and more than 25,000 hours of bioinformatic, analytical and data management support to the user community. As outlined in the call, EASI-Genomics will provide access to advanced methods that go beyond what is commercially available. The focus will be on more complex procedures involving short-reads, long-reads, in situ sequencing and single-cell analysis. Complex integrative projects and projects on non-human samples will also be highlighted. Finally, EASI-Genomics will support the wider NGS community to improve their quality control processes by offering open inter-laboratory comparisons allowing them to obtain ISO certification and accreditation in line with many of the EASI-Genomic partners. The EASI-Genomics project aims to build a community of practice, which leverages advanced sequencing technologies beyond country and sector borders to tackle global challenges in science.

Molecular in vitro diagnostics and biomedical research have allowed great progress in personalised medicine but further progress is limited by insufficient guidelines for pre-analytical workflow steps (sample collection, preservation, storage, transport, processing etc.) as well as by insufficient quality assurance of diagnostic practice. This allows using compromised patients’ samples with post collection changes in cellular and extra-cellular biomolecules’ profiles thus often making diagnostic test results unreliable or even impossible. To tackle this, SPIDA4P aims to generate and implement a comprehensive portfolio of 22 pan-European pre-analytical CEN/Technical Specifications and ISO/International Standards, addressing the important pre-analytical workflows applied to personalized medicine. These will also applicable to biomarker discovery, development and validation as well as to biobanks. Corresponding External Quality Assurance (EQA) Schemes will be developed and implemented as well, aiming to survey the resulting quality of samples and diagnostic practice. SPIDIA4P will ensure stakeholder organisations involvements as well as training, education, and counselling as additional major foci of the project. The consortium will closely coordinate with large European public research consortia to obtain access to research and validation studies data serving as evidence for the new standards developments and achieved improvements of diagnosis, patient stratification and prognosis of disease outcome. At this crucial moment in the development of personalised medicine, SPIDIA4P proposes a coordination and support action that reunites 19 highly experienced partners in international standardisation for in vitro diagnostics, coming from private industry including SMEs, public institutions and from one official European Standards Organisation. This strong consortium is balanced and empowered to maximise the impacts of in vitro diagnostics on personalised medicine.