AliveDx, a leading player in diagnostic innovation, is proud to announce the recent achievement of IVDR-CE mark certification for its MosaiQ AiPlex™ CD microarray immunoassay, a groundbreaking multiplexed solution designed to enhance the accuracy and speed of diagnosing celiac disease (CD). This certification indicates that the assay complies with the rigorous In Vitro Diagnostic Regulation (IVDR) standards set by the European Union. As a result, it is now ready for clinical use across regions that recognise CE mark certification, broadening AliveDx’s global reach and impact in revolutionising patient care for those living with celiac disease.
Addressing the Global Challenge of Celiac Disease
Celiac disease is a long-term autoimmune condition with a worldwide prevalence, impacting 1 in every 100 individuals. This condition, primarily affecting the small intestine, results from an abnormal immune response to gluten, a protein found in wheat, barley, and rye. In genetically predisposed individuals, the ingestion of gluten triggers the production of autoantibodies, causing damage to the small bowel and leading to a range of multiorgan clinical symptoms.
Diagnosing celiac disease is a complex process, usually involving serological tests for specific autoantibodies in combination with other clinical, laboratory, imaging, genetic, and histopathological assessments. Current clinical guidelines recommend testing for IgA autoantibodies against tissue transglutaminase (tTG IgA) and deamidated gliadin peptides (DGP IgA). However, some individuals with celiac disease have selective IgA deficiency, requiring additional testing for IgG autoantibodies (such as tTG IgG and DPG IgG) to confirm the diagnosis.
MosaiQ AiPlex CD Microarray:
AliveDx’s newly CE-marked MosaiQ AiPlex CD microarray immunoassay offers healthcare providers an efficient and reliable solution to streamline celiac disease diagnostics. This innovative assay includes the most clinically relevant autoantibodies—tTG IgA, DGP IgA, tTG IgG, DGP IgG, as well as total IgA levels—allowing for more comprehensive insights using just a single blood sample. The MosaiQ AiPlex CD is specifically designed to simplify laboratory workflows, reducing diagnostic delays, while providing fast, actionable results for patients. Early diagnosis allows individuals with celiac disease to promptly begin a gluten-free diet (GFD), which can alleviate gastrointestinal symptoms and prevent long-term health complications.
Expanding Diagnostic Possibilities
The MosaiQ AiPlex CD microarray is a part of AliveDx’s broader portfolio, which includes the MosaiQ, MosaiQ AiPlex CTD, and LumiQ platforms, designed to provide a comprehensive autoimmune and allergy diagnostic solution. AliveDx plans to expand the menu of its MosaiQ autoimmune and allergy portfolio significantly in 2025 and beyond, offering more advanced diagnostic options to laboratories around the world.
Commitment to Diagnostic Innovation and Patient Care
“We are excited to have earned the IVDR-CE mark for our MosaiQ AiPlex CD microarray,” stated Manuel O. Mendez, CEO of AliveDx. “This represents the fourth CE mark approval for our microarray technology in the last year, underscoring our dedication to advancing diagnostic technologies that facilitate early and precise diagnoses. The rapid expansion of the MosaiQ portfolio underscores our dedication to improving patient outcomes, reducing healthcare costs, and enhancing the quality of life for those living with autoimmune diseases, including celiac disease.”
AliveDx remains committed to empowering clinicians and laboratorians with innovative diagnostic tools that foster better patient care. The MosaiQ AiPlex CD microarray represents a significant step forward in celiac disease diagnostics, enabling more efficient and accurate testing, ultimately improving clinical outcomes and quality of life for millions of people worldwide.
