AliveDx has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its MosaiQ AiPlex® Celiac Disease (CD) microarray, marking a significant step toward bringing this innovative diagnostic tool to the U.S. market. The multiplex assay, which received IVDR-CE mark certification in August 2024, represents a potential breakthrough in celiac disease diagnosis.
Advanced Diagnostic Capabilities
The MosaiQ AiPlex CD platform introduces a comprehensive approach to celiac disease testing, combining multiple critical markers in a single panel. The system can process up to 425 disease markers per hour, utilizing just 20 μl of patient sample to analyze both IgA and IgG isotypes simultaneously. This capability is particularly crucial given that celiac disease affects approximately 1 in 100 people globally and can present with various multiorgan clinical symptoms.
The assay incorporates five key markers aligned with major clinical guidelines from ESsCD, ACG, and ESPGHAN, providing simultaneous detection of IgA deficiency and quantitative values for anti-tTG and anti-DGP antibodies. This comprehensive approach is especially valuable considering that IgA deficiency can be up to 15 times more prevalent in celiac disease patients.
Streamlined Laboratory Workflow
The platform features several technological advances designed to enhance laboratory efficiency:
- Microarray-internal calibration
- Integrated quality control systems
- RFID-tagged reagents and microarray magazines
- Continuous random access testing capabilities
Manuel O. Méndez, CEO of AliveDx, emphasized the platform's potential impact: "Considering that the average time to diagnose an autoimmune disease can exceed four years, the need for a multiplexed solution to accelerate diagnosis is essential. The MosaiQ AiPlex CD solution addresses this need by enabling early disease detection and facilitating more targeted and effective treatments."
Clinical Significance
Celiac disease, a chronic autoimmune disorder primarily affecting the small intestine, requires accurate and timely diagnosis for effective management. The condition is triggered by gluten consumption in genetically susceptible individuals, leading to autoantibody production and intestinal damage. The MosaiQ platform's ability to provide comprehensive serological evaluation helps healthcare providers more efficiently rule in or rule out celiac disease.
The system's syndromic approach to testing represents a significant advancement in autoimmune disease diagnostics, potentially reducing diagnostic delays while improving laboratory efficiency. This combination of comprehensive testing and streamlined workflows could significantly impact both laboratory operations and patient care outcomes.
