Celiac disease impacts approximately 0.7% (confirmed by biopsy) to 1.4% of the global population (based on positive results for celiac disease antibodies)[1], yet it remains significantly underdiagnosed. This autoimmune condition, triggered by gluten ingestion, can lead to severe intestinal damage, malabsorption, and long-term complications if left untreated. For clinical laboratories and healthcare providers, accurate and timely diagnosis is critical, not only to improve patient outcomes, but also in the reduction of healthcare costs associated with delayed or missed diagnoses.
What is celiac disease?
Celiac disease is a systemic autoimmune disorder where the ingestion of gluten, a protein found in wheat, barley and rye, triggers an immune response that damages the small intestine in genetically predisposed individuals[2]. Symptoms range from gastrointestinal issues like diarrhoea and bloating to systemic effects such as anaemia, osteoporosis, and fatigue. Importantly, celiac disease is not an allergy or intolerance; it is a chronic autoimmune condition that requires lifelong management once accurate diagnosis has been established.
[1] Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis
[2] Clinical Chemistry and Laboratory Medicine, 2025
Traditional in-vitro diagnostic test pathways
Recent advances include non-biopsy approaches for selected patients, AI-assisted histology interpretation, and novel blood tests like IL-2 assays that eliminate the need for gluten challenges[3]. These innovations are impacting in-vitro diagnostic workflows, making them faster and less invasive with each scientific progression.
The MosaiQ® solution: Multiplex microarray testing transforms celiac disease diagnostics
AliveDx is advancing autoimmune diagnostics with MosaiQ®, a fully automated, high-throughput system designed to simplify complex testing workflows. At the centre of this innovation is the MosaiQ AiPlex® CD microarray assay which enables simultaneous detection of key celiac disease markers: anti-tTG and anti-DGP antibodies (IgA and IgG), alongside total IgA assessment in a single step.
[3] Clinica Chimica Acta, 2024
AliveDx’s multiplex approach reduces the need for individual single plex assays, accelerating turnaround times and providing clinicians with fast and reliable results. Studies presented at major congresses have demonstrated positive percent agreement (PPA) up to 100% and negative percent agreement (NPA) up to 99%. [4]
[4] Data on file
AliveDx support accurate coding and reimbursement
Beyond the clinical and patient benefits, our MosaiQ solution also supports administrative requirements associated to healthcare. By delivering clear, lab-confirmed evidence of celiac disease, the platform enables clinicians and laboratories to confidently apply ICD-10 codes such as K90.0 (Celiac disease), Z13.811 (Screening for celiac disease), and Z86.2 (Personal history of celiac disease). Accurate coding is essential for reimbursement, compliance and epidemiological tracking.
Multiplex testing not only support enhanced patient care and lab workflows, but also strengthens documentation workflows, ensuring that finance departments, public health institutions and clinical labs have reliable data for resource planning, ongoing disease monitoring and accurate clinical data for analysis.
Celiac Disease ICD-10
Accurate coding supports reimbursement and epidemiological tracking. Coding and clinical documentation:
Is Celiac Disease Genetic?
Over 95% of patients carry either the HLA-DQ2 or HLA-DQ8 gene variants, which predispose individuals to the disease[5]. However, genetics alone do not guarantee development; environmental triggers and immune dysregulation also play roles.
[5] Clinical Chemistry and Laboratory Medicine, 2025
Is Celiac Disease a Disability?
In many jurisdictions, celiac disease is recognized as a disability because it substantially limits important life activities, particularly eating and digestion. This classification can impact workplace accommodations and insurance coverage, not only impacting health but also how people live their lives.
Refractory Celiac Disease
A rare but serious complication refractory celiac disease (RCD) occurs when symptoms and intestinal damage persist, despite strict adherence to a gluten-free diet for at least 6–12 months[6].
[6] Clinica Chimica Acta, 2024
Early detection and monitoring are essential to prevent progression and further complications.
Celiac Disease Diets
The cornerstone of management remains a strict gluten-free diet. However, adherence can be challenging, and nutritional deficiencies are common. Emerging therapies such as immune modulation and enzyme supplementation may complement dietary management in the future.
To learn more about AliveDx and the work we do to help accelerate lab workflows and better support patient care, contact us today.
*Certain assays and intended uses for the MosaiQ® are currently under development and are not yet cleared by the U.S. Food and Drug Administration. The MosaiQ solution is IVDR-CE Marked and available in the U.S. as a class II 510(k) exempt device.
*The MosaiQ AiPlex® CD panel is IVDR-CE marked but currently not available for use in the US and/or all global regions.
©2025 – AliveDx Suisse SA – AliveDx, AliveDx logo, MosaiQ, AiPlex and MosaiQ AiPlex are trademarks or registered trademarks of AliveDx group companies in various jurisdictions. Not all methods may be available in all territories. Subject to regulatory clearance in some territories.
References
- 1. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis
- 2. Clinical Chemistry and Laboratory Medicine, 2025
- 3. Clinica Chimica Acta, 2024
- 4. Data on file
- 5. Clinical Chemistry and Laboratory Medicine, 2025
- 6. Clinica Chimica Acta, 2024
- 7. American Journal of Gastroenterology, 2024
