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INtegrated and STANDardized NGS workflows FOR Personalized therapy (Instand-NGS4P) - a short presentation

INSTAND-NGS4P is an EU-funded Pre-Commercial Procurement (PCP) project for improving cancer patients' benefit from Next Generation Sequencing (NGS) by developing an integrated and standardized NGS workflow. For this, it will compile information from cancer gene testing, pharmacogenetics testing and e-medication in proper presentation to medical doctors for supporting therapy decision making at bedside widely applicable in health systems (http://www.instandngs4p.eu/).

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Major challenges to be addressed are: • Improving the analytical performance by standardizing pre-analytical processes • Integrating pre-analytical, analytical processes and data analytics into a standardized workflow • Defining genetic variants with established medical implications for common and rare cancer of adult and pediatric cancers including pharmacogenetic variants relevant for drugs used in cancer care • Developing reference material for quality control • Meeting requirements of the European in vitro-diagnostics regulation • Improving benefits for patients and health systems from NGS Instand-NGS4P is a 60-month PCP project – which started January, 1st 2020, with 18 partners federating: • 7 European leading medical centres from 5 countries (two are coordinating European Reference Networks) as the buyers’ group; they have major experience in using different NGS platforms in research and routine diagnostics: led by the Medical University of Graz (MUG - the lead procurer - AT), jointly with the University of Florence (UNIFI - IT), the ERASMUS University Medical Centre (EMC - NL), the University of Milano-Bicocca (UNIMIB - IT), the University Clinics of Schleswig-Holstein (UKSH - DE), and the two coordinating ERNs on cancer: St. Anna Kinderkrebsforschung (CCRI - AT) and the Centre Leon Bérard (CLB - FR), devoted to rare paediatrics cancers and adult rare cancers, respectively; • 2 European patient advocacy groups, represented by the Italian Patient Association (FAVO - IT) and the European Cancer Patient Coalition (ECPC - BE); • a standardization organization (German Institute of Standardisation (DIN)), and universities involved in development of pre-analytical standards with the Technical University of Munich (TUM - DE), MUG, UNIFI and EMC; • partners participating in the European Research infrastructures BBMRI-ERIC (MUG, UNIMIB), and ELIXIR through the Slovenian node, the University of Ljubljana; • as well as several partners involved in NGS-related EU programs to cover all technical aspects and transversal needs & requirements: the University of Manchester (Uniman - UK) and the University of Liverpool (UoL - UK) connecting to the 100,000 Genomes Project and the UK Biobank with pharmacogenomics; the Organisation of European Cancer Institutes (OECI - BE) representing 92 entities, 13 Clinical Accredited Centres and 18 Accredited Comprehensive Cancer Centres, and the University of Helsinki (UH - FI) involved in the FIMM network; • one SME, BioXPedia, who will act as future potential buyer; and • iPRI (International Prevention Research Institute - FR), ensuring transparent dissemination of research worldwide. Key figures: 12.22 M€ for Instand-NGS4P, with EC funding share of nearly 11 M€. The 7 leading clinical centres decide to procure jointly in a pre-commercial step, to achieve the ambitious objectives. 8.55 M€ is to be allocated to the R&D suppliers, who will be selected based on public tenders all along this PCP process comprising 3 phases according to the best value for money solution, after the closure of the preparation phase. This preparation phase will involve an Open Market Consultation (OMC) to ensure proper alignment between the patient and clinical needs with the 7 leading clinical centres – representing a guarantee on developing the required critical mass to achieve this ambitious program, and the R&D service providers’ community concerning technical feasibility as well as the regulatory and payers’ bodies. Based on the feedback from the OMC, the call for tenders will be published for PCP R&D suppliers addressing the requirements of all 3 PCP phases in a single call. It will be opened to all types of industrials. These 3 phases foresee the leverage of the 4 technical lots (i.e. on pre-analytics, sequencing, bioinformatics, e-reporting/e-medication) and their standardized interfaces, to be assembled in a fully integrated NGS workflow. Dates to be refined. Stay tuned - http://www.instandngs4p.eu/

Keywords

NGS, personalised medicine, diagnostics, cancer, routine, paediatrics, adult, PCP