Instand e.V.

Ubierstraße 20
Düsseldorf,  40223

Germany
www.instand-international.com

• Booth: 4258

 Press Releases

• Lessons from External Quality Control in Laboratory Medicine (Oct 02, 2024)
  Lessons from External Quality Control in Laboratory Medicine: Important Implications for Public Health!
  
  Topic editors:
  Prof. Klaus-Peter Hunfeld, Prof. Han sotto Reiber, Prof. Piet Meijer, Prof. Peter Luppa, Prof. Dirk Schluter, Prof. Michael Spannagl, Prof. Douglas Norris, and Prof. lngo Schellenberg
  
  Data on the impact of laboratory testing quality on public health and patient care are scarce, despite billions of tests worth trillions of dollars being performed annually worldwide. Medical testing remains largely underregulated, with quality control measures often provided by manufacturers, leaving many tests unevaluated by robust clinical studies.
  
  External quality control measures, such as round robin trials and surveys, are crucial for assessing modern assay quality. Greater understanding of in vitro diagnostics and issues related to test quality in laboratory medicine is needed, along with the impact of these issues on medical care and public health.
  
  This Research Topic highlights lessons from INSTAND. e.V., Duesseldorf, an independent scientific society focused on external quality control in laboratory medicine over the past 20 years. It addresses regulatory issues in molecular diagnostics and the identification of
  diagnostic and therapeutic tools for clinical use. This collection aims to shed light on problems with insufficiently evaluated test systems and their impact on medical care and public health.
  
  Findings from the included studies will enhance our understanding of how test quality affects patient care both individually and broadly, ultimately aiming to improve future medical care and high-quality patient management.
  
  For any questions, please contact us at instand@instand-ev.de

• INSTAND participates in the EU-funded joint research project for the manufa (Dec 13, 2024)
  INSTAND participates in the EU-funded joint research project for the manufacturing of commutable calibrators and quality control materials since September 2024
  
  For the EU-funded joint research project under the auspices of the European Association of National Metrology Institutes (EURAMET), European National Metrology Institutes, Designated Institutes and partners from medicine, science and industry have joined forces for the project “Manufacturing of commutable calibrators and quality control materials for standardisation and post-market surveillance of IVD tests” (short name COMET). The 3-year project started in September 2024 and aims to establish and provide the necessary metrological infrastructure, knowledge, and services for in vitro diagnostic (IVD) manufacturers to meet the European requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR) EU/2017/746.
  
  According to the IVDR EU/2017/746, the metrological traceability of values assigned to calibrators and control materials shall be assured through certified reference materials (CRMs) of a higher metrological order and suitable reference measurement procedures (RMPs) to ensure a consistently high standard of IVD tests in Europe. Nowadays, manufacturers of commercial IVD tests are often unable to comply with these regulations because appropriate CRMs and RMPs are not yet available. The COMET project aims to reduce this gap by focusing on the metrological traceability and performance verification in order to support the IVD industry to meet the future legal requirements. This will be achieved through a functional metrological infrastructure which can offer cost-effective calibration services to IVD manufacturers and through the production of new CRMs and quality control materials which are needed for standardisation, harmonisation, and post-market surveillance of IVD tests through internal and external quality assessment (EQA). Furthermore, the project focuses on the complex subject of commutability, on general causes of non-commutability and on developing more efficient commutability studies with the overall objective to manufacture and provide commutable control materials.
  
  In more detail, the COMET project seeks to develop SI-traceable, primary reference materials, fit for purpose calibrators and quality control materials with a focus on specific measurands including among others cyclosporine, parathyroid hormone (PTH), human cytomegalovirus (HCMV), bilirubin, estradiol, and panels of clinically relevant biomarkers and therapeutic drugs. These calibrators and control materials shall then be applicable for IVD manufacturers as well as EQA providers for evaluating and verifying the metrological traceability of clinical tests. Another project objective is to simplify the commutability assessment by developing more cost-effective and efficient commutability studies through abbreviated or multiparameter studies, the use of commutability panels and high-throughput RMPs as well as highly automated data analyses. For the high-throughput RMPs, the main project focus is on the measurands estradiol, PTH, and a panel of therapeutic drugs. For the commutability studies, a panel of clinically relevant biomarkers, bilirubin, PTH, HCMV, a panel of therapeutic drugs, and point-of-care tests for glucose will be investigated. Furthermore, at least one accuracy-based EQA scheme circulating commutable EQA material with assigned reference method target values will be conducted. Also, a European database shall be established where EQA data and information on commutable control materials are aggregated and shared with metrology institutes and industry partners. Finally, the COMET project seeks to create a lasting impact by providing the generated knowledge and measurement infrastructure to various stakeholders as IVD manufacturers, material producers, EQA providers, standards developing organisations, and medical associations.
  Overall, the improvements and achievements of the COMET project will facilitate IVD manufacturers to comply with the requirements of the IVDR EU/2017/746 and even further international standards. Thereby, it will contribute to high quality standards of IVD tests and patient safety in general.
   

• Pioneering Cancer Treatments through Enhanced Genomic Profiling in the Geno (Mar 13, 2025)
  In the face of a rising global cancer crisis, with a death toll of 1.3 million in 2020 and an anticipated 32% increase in cases by 2040¹ in Europe, the accurate profiling of cancer's genetic makeup is acritical tool in its treatment.
  Increasingly, genomic profiling is being used to advance cancer treatment, utilising detailed genetic mapping to enable earlier diagnoses and personalised therapies. The essence of this lies in genome sequencing, notably through techniques such as Next Generation Sequencing (NGS), which provide key insights about the nature of the disease. However, the analytical complexity of genome sequencing introduces significant uncertainties. Metrology (measurement science) is fundamental to overcome these challenges and provide confidence in data to support timely access to accurate cancer diagnostics and therapies. A new project under the European Partnership for Metrology, seeks to address these challenges.
  GenomeMET, a collaborative project, is focussed on developing a robust metrological (measurement) infrastructure to support method validation and quality control at both the pre-analytical and analytical stages. The consortium, led by the Istituto Nazionale di Ricerca Metrologica (INRiM – the Italian metrology institute) includes leading European metrology institutes, instrument manufacturers, EQA scheme providers (e.g. INSTAND, Germany), regulatory bodies, and clinical laboratories. The project will also develop reference measurement procedures for measuring genomic biomarkers. This will support improved accuracy and comparability of genomic profiling across European healthcare systems in support of Horizon Europe’s Mission on Cancer.
  Beyond its clinical implications, the outcomes of the GenomeMET project have the potential to ease the economic burden of cancer, which in Europe is €141.8 billion annually (1.07 % of GDP)², and reduce reliance on single-use diagnostic materials, thereby contributing to a more sustainable healthcare model.
  Enabling wider roll out of genomic testing is not just about tackling cancer; it’s about improving the quality of life and patient outcomes, ensuring that treatments are as unique as the individuals receiving them.
  “We hope that GenomeMET can help improve personalized medicine and that it can be the first of a series of projects aimed at improving NGS protocols” said Carla Divieto, the project coordinator.
  By embedding metrology within genomic profiling, this project will support earlier and more accurate cancer diagnosis, alongside tailored treatment strategies, marking a significant stride towards a future where cancer treatment is not just a standard procedure but a personalised journey towards recovery.
  For more information on the GenomeMET project, please visit https://www.genomemet.org/,  https://www.euramet.org/research- innovation/search-research-projects/details/project/metrology-for-genomic-profiling-to-support- early-cancer-detection-and-precision-medicine   and www.linkedin.com/company/genomemet/. Further inquiries or engagement opportunities can be directed to Carla Divieto (c.divieto@inrim.it) and Carole Foy (Carole.Foy@lgcgroup.com).
  
  ¹ Data explorer | ECIS (europa.eu)
  ²The Cancer Atlas. Https://Canceratlas.Cancer.Org/Taking-Action/Economic-Burden/; 2022
  
  PROJECT PARTNERS

  no.	Short Name	Organisation legal full name	Country
  1	INRIM	Istituto Nazionale di Ricerca Metrologica	Italy
  2	LNE	Laboratoire national de métrologie et d'essais	France
  3	NIB	Nacionalni Institut za Biologijo	Slovenia
  4	PTB	Physikalisch-Technische Bundesanstalt	Germany
  5	TUBITAK	Turkiye Bilimsel ve Teknolojik Arastirma Kurumu	Türkiye
  6	CEA	Commissariat à l'énergie atomique et aux énergies alternatives	France
  7	FPO	Fondazione del Piemonte per l'Oncologia	Italy
  8	INSTAND	INSTAND e.V. - Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V.	Germany
  9	MUG	Medizinische Universität Graz	Austria
  10	UNITO	Università degli Studi di Torino	Italy
  11	BIORAD	BIORAD Laboratories, Inc.	United States
  12	GenQA	GenQA Ltd	United Kingdom
  13	LGC	LGC Limited	United Kingdom
  14	METAS	Eidgenössisches Institut für Metrologie METAS	Switzerland
  15	MHRA	Medicines and Healthcare Products Regulatory Agency	United Kingdom
  16	ULE	University of Leeds	United Kingdom