A new, JRC-developed control material to improve the accuracy of diagnosis
The Joint Research Centre (JRC) of the European Commission has developed the world’s first certified reference material (CRM) with universal characteristics to improve the accuracy of coeliac disease testing. This development represents a critical step toward harmonising medical diagnostics, addressing long-standing challenges in ensuring consistent, reliable results across laboratories, and ultimately enhancing treatment outcomes for patients.
The accurate diagnosis of coeliac disease depends on the measurement of specific biomarkers – especially anti-tTG antibodies found in the blood. While various tests are available, results often vary from lab to lab due to differences in testing methods and a lack of international standardisation. This variation poses a serious risk: when test results are not comparable, patients may receive incorrect or delayed diagnoses, potentially leading to inadequate or misguided treatment and long-term health consequences.
In response to this need, the JRC has released a new CRM to serve as a calibration standard for medical laboratories. The material was produced in collaboration with the UK’s Medicines and Healthcare products Regulatory Agency, a WHO collaborating centre. Part of the batch has been recognised as the first official WHO international standard for anti-tTG antibodies. The remaining portion, certified by the JRC, is now available as a CRM for use in clinical and diagnostic laboratories.
Universal applicability
What makes this reference material particularly significant is its universal applicability. It can be used across different testing platforms, regardless of the laboratory, diagnostic method, or geographical setting. By establishing a common benchmark, the material ensures greater consistency and comparability, contributing to more accurate diagnoses and reducing disparities in healthcare access and quality across the EU and beyond.
This innovation holds important implications not only for healthcare providers and diagnostic developers, but also for regulatory bodies and patients themselves. Reliable testing is crucial for clinical decision-making, long-term disease monitoring, and the development of new diagnostic tools. It also has downstream effects on public health policy, allowing more effective screening programs and epidemiological research into autoimmune conditions.
Coeliac disease, an autoimmune disorder triggered by gluten consumption in genetically predisposed individuals, affects around 1% of the EU population – approximately 4.5 million people. It damages the small intestine and impairs nutrient absorption, causing a range of complications if left untreated. Diagnosis is often delayed or missed entirely, further underlining the need for harmonised and accurate testing methods.
ERM-DA487_IFCC HUMAN SERUM (anti-tTG lgA and lgG) – The world’s first certified reference material for anti-tTG antibodies, developed by the European Commission’s Joint Research Centre. This universal calibration tool improves diagnostic accuracy, enabling harmonised and reliable coeliac disease testing across laboratories worldwide.
Better standardisation
The JRC’s initiative is also closely aligned with broader priorities in food safety. Since there is no cure for coeliac disease, the only effective treatment is a lifelong gluten-free diet. This makes accurate food labelling essential. According to EU legislation, products may be labelled “gluten-free” only if they contain less than 20 mg of gluten per kilogram. However, JRC researchers recently published a study warning of risks associated with certain “gluten-reduced” barley beers, which are sometimes mislabelled due to limitations in current analytical methods.
Their findings call for better standardisation of gluten detection techniques in food products. Specifically, the study highlights difficulties in detecting degraded gluten proteins in beer, a lack of reliable reference materials, and insufficient in vivo toxicity data. In response, the JRC recommends the development of appropriate reference materials, improved analytical protocols, and production methods that ensure true safety for coeliac consumers.
New possibilities
The creation of this CRM is part of a larger strategy by the JRC to support scientific reproducibility and clinical reliability. With autoimmune diseases affecting between 5% and 10% of the European population, the development of high-quality, harmonised testing materials is a vital contribution to public health and medical innovation. It also opens new possibilities for companies designing diagnostic platforms, assay kits, or digital health tools: for the first time, developers have a shared foundation they can build on with confidence.
This milestone supports the broader growth of precision diagnostics and personalised medicine. Companies in the life sciences and health-tech sectors can use this CRM to develop more reliable, interoperable diagnostic products – solutions that not only meet clinical needs but are also better positioned for regulatory approval and market adoption across the EU and internationally.
Laying the foundation for future health tech solutions
Looking ahead, this effort lays the groundwork for further innovation. From AI-driven diagnostic software calibrated on standardised data, to in vivo toxicity assessments and validated gluten detection kits, the potential for new products and services is wide-ranging. It also strengthens collaboration between public health institutions and private industry, encouraging shared investment in tools that can transform diagnosis, monitoring, and ultimately, patient quality of life.
For researchers, developers, and entrepreneurs working at the intersection of healthcare and technology, the release of this CRM is an enabler of innovation. This initiative reflects the JRC’s broader commitment to improving clinical measurement reliability and supporting public health policy across Europe. In the context of autoimmune disorders, which affect up to 10% of the population, it marks a strategic step forward – one that connects scientific excellence, regulatory alignment, and innovation in life sciences.
References
- https://joint-research-centre.ec.europa.eu/jrc-news-and-updates/first-ever-certified-reference-material-improve-diagnosis-coeliac-disease-2025-05-19_en
- Reference materials for clinical analysis – Joint Research Centre EU
- Cubero‑Leon, E., Madsen, C. B., Scherf, K. A., Colgrave, M. L., Nørgaard, J. V., Anthoni, M., Rizou, K., Walker, M. J., & Sollid, L. M. (2024, 20 settembre). Barley based gluten free beer – A blessing or an uncontrollable risk? Food and Chemical Toxicology, 193, 115019.
