AliveDx Submits FDA 510(k) for MosaiQ AiPlex® Celiac Disease Test to Revolutionize Diagnosis

Revolutionizing Celiac Disease Diagnosis

AliveDx has announced a significant move towards enhancing the diagnostic landscape for celiac disease by submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative MosaiQ AiPlex® Celiac Disease (CD) multiplex microarray. This advanced microarray is engineered to streamline laboratory workflows while drastically improving both the accuracy and speed of celiac disease diagnosis.

Celiac disease is an autoimmune disorder characterized by an abnormal immune response to gluten, a protein found in wheat, barley, and rye, affecting approximately 1 in 100 individuals worldwide. Left untreated, it can lead to serious health complications, making timely and precise diagnosis crucial. Celiac disease’s diverse symptoms can often result in misdiagnosis or delayed detection, taking an average of four years for patients to receive an accurate diagnosis.

The MosaiQ AiPlex CD multiplex assay, which received its IVDR-CE mark certification in August 2024, offers a comprehensive solution by supporting a syndromic approach. This means that healthcare providers can assess multiple factors simultaneously, simplifying the screening process. The panel combines both IgA and IgG isotypes, requiring just a 20 μl blood sample from the patient without saturating laboratory resources.

Key Features of the MosaiQ AiPlex® CD Test

The MosaiQ AiPlex CD assay is designed for high efficiency and effectiveness. It incorporates five key markers that align with current clinical guidelines from leading gastroenterological societies, thereby ensuring a thorough and relevant analysis paradigm. The inclusion of autoantibodies provides healthcare providers with intricate details surrounding patients’ immune responses, essential for an accurate diagnosis.

Moreover, this cutting-edge test enables clinicians to check for IgA deficiency, which is notably prevalent among individuals with celiac disease, found at rates up to 15 times higher than the general population. The ability to detect such deficiencies alongside gluten-related markers creates a fuller, more reliable diagnostic picture.

According to Manuel O. Méndez, CEO of AliveDx, “Today’s submission brings us one step closer to providing a critical tool for healthcare facilities across the United States. By accelerating diagnosis through a multiplexed solution, we can facilitate earlier disease recognition and hence more tailored therapeutic strategies, offering substantial relief for patients.”

Enhancing Laboratory Efficiency

In addition to its diagnostic capabilities, the MosaiQ solution is touted for its efficient workflow. By consolidating multiple tests into one comprehensive panel, it reduces the hands-on time required by laboratory staff, thus allowing for better allocation of resources. This is especially crucial in busy diagnostic environments where speed and accuracy are paramount.

The assay’s design allows for high throughput, processing up to 425 disease markers per hour—an impressive feat aimed at reducing the backlog in laboratories and improving patient turnaround time. The incorporation of RFID tags in all reagents and microarray magazines helps minimize manual errors, saving time and enhancing quality control throughout the testing process.

About AliveDx

Founded with a mission to transform patient care through enhanced diagnostics, AliveDx has over 30 years of experience in the in-vitro diagnostics industry. The company is committed to reshaping the future of global diagnostics not just for autoimmune diseases, but across diverse medical needs including allergies and beyond. Key offerings include the brands Alba, MosaiQ, and LumiQ, all designed to enhance laboratory workflows and produce rapid, accurate results that support clinical decision-making.

For more information regarding AliveDx and their innovative IVD solutions, please visit www.alivedx.com or connect with them on LinkedIn and X.