AliveDx Files 510(k) Submission with FDA for Innovative MosaiQ AiPlex® Celiac Disease Test

AliveDx's Innovative Approach to Celiac Disease Testing

On February 10, 2025, AliveDx announced its submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® microarray test designed specifically for the diagnosis of celiac disease. This move comes as part of the company's commitment to revolutionize diagnostic testing in a field where speed and accuracy can make a significant difference in patient care.

Enhancing Diagnosis with MosaiQ AiPlex®

The MosaiQ AiPlex® multiplex test aims to improve both the precision and speed of celiac disease diagnoses while simplifying laboratory workflows. Recent data shows that the average time to diagnose autoimmune diseases like celiac disease can exceed four years, highlighting the urgent need for more efficient testing solutions. The MosaiQ AiPlex® system addresses this issue, offering healthcare providers a syndromic approach to testing.

Celiac disease, an autoimmune disorder affecting approximately 1 in 100 individuals globally, causes damage to the small intestine when gluten is ingested. The resulting immune response can lead to the development of various autoantibodies, complicating diagnosis.

Streamlined Workflow for Healthcare Providers

The MosaiQ AiPlex test requires only a 20 μl sample from each patient to perform a comprehensive analysis that includes a panel of five key markers. This multi-marker format combines the testing of IgA and IgG isotypes to provide healthcare professionals with pertinent information quickly and efficiently, enhancing the overall patient experience.

Manuel O. Méndez, CEO of AliveDx, expressed his enthusiasm about the submission, emphasizing the significance of early detection for effective treatment. He stated, "The introduction of our multiplex solution addresses an essential need in detecting celiac disease early, leading to more targeted treatments for patients."

Comprehensive Testing Capabilities

Specifically designed to identify up to 425 disease markers per hour, the MosaiQ AiPlex test combines the essential autoantibodies recommended by clinical guidelines from leading gastrointestinal societies like ESsCD, ACG, and ESPGHAN. It also screens for IgA deficiencies, which are significantly more prevalent in patients with celiac disease.

A Vision for the Future

AliveDx aims to enhance diagnostic understanding, improve patient care, and drive innovation within healthcare. With over 30 years of experience in in vitro diagnostics, the company is dedicated to shaping the future of global diagnostics for autoimmune diseases and allergies, among others. The MosaiQ solution is designed not just for greater efficiency in diagnostics but also to provide healthcare providers with valuable insights for decision-making.

In addition to its strong focus on clinical efficacy, the MosaiQ platform employs fully automated multiplex testing. The integration of RFID technology in the multiplex assay system minimizes human errors and optimizes laboratory workflows, leading to faster patient turnaround times.

Conclusion

The FDA's evaluation of AliveDx’s 510(k) submission for the MosaiQ AiPlex® celiac disease microarray marks a significant milestone in the fight against autoimmune disorders. If approved, this innovative approach to celiac disease diagnosis could greatly enhance diagnostic speed and accuracy, contributing to improved patient management and outcomes. As celiac disease continues to affect a substantial segment of the population, the MosaiQ AiPlex® system represents hope for timely and effective diagnosis and treatment of this chronic condition.

For more information about AliveDx and its pioneering diagnostic solutions, visit www.alivedx.com and connect with the company on LinkedIn and social media platforms.