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AliveDx Submits 510(k) Notification for MosaiQ AiPlex® Celiac Disease Test

In a significant step towards improving healthcare diagnostics, AliveDx has recently lodged a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) for its innovative MosaiQ AiPlex® Celiac Disease (CD) test. This submission marks a pivotal moment for the company, intended to refine the accuracy and speed of celiac disease diagnosis while streamlining laboratory workflows.

About the MosaiQ AiPlex CD Test

The MosaiQ AiPlex CD test is designed as a multiplex solution that enhances the diagnostic process for celiac disease—an autoimmune disorder that affects approximately 1 in 100 individuals worldwide. This condition primarily impacts the small intestine and manifests with varied symptoms across multiple organ systems. Triggered by gluten consumption in genetically susceptible individuals, celiac disease leads to an abnormal immune response, characterized by the production of auto-antibodies and subsequent intestinal damage.

Leveraging recent advancements in diagnostics, the MosaiQ AiPlex CD combines both IgA and IgG isotypes, enabling healthcare providers to conduct a comprehensive serological assessment with only 20 microliters of patient sample in a single assay. This innovative approach not only ensures high sensitivity and specificity but also facilitates actionable insights for healthcare professionals, improving patient care significantly.

Key Features of the Test

The multiplex panel included in the MosaiQ AiPlex CD assay consolidates five critical biomarkers aligned with contemporary clinical guidelines (ESsCD, ACG, and ESPGHAN). Besides, it instantaneously detects IgA deficiencies, greatly beneficial as this deficiency is reported to be up to 15 times more prevalent in celiac patients.

Manuel O. Méndez, CEO of AliveDx, expressed enthusiasm over the FDA application, stating, “With the average time to diagnose an autoimmune condition often exceeding four years, our multiplex solution aims to accelerate this process. By enabling early detection of celiac disease, we can pave the way for more focused and effective treatments, ultimately bringing much-needed relief to affected patients.”

Workflows and Efficiency Gains

The MosaiQ solution is tailored to deliver a simplified workflow and rapid outcomes. Its design allows for simultaneous testing of up to 425 disease markers per hour, significantly minimizing the turnaround time for laboratory results. Further, the integrated calibration and multi-analyte quality controls ease the operational demands on laboratories and practitioners alike.

To bolster accuracy and efficiency, all reagents and multiplex test kits are embedded with RFID tags, which are instrumental in minimizing manual errors and expediting processes. This level of automation is expected to reshape how laboratories operate, enhancing both productivity and the quality of patient outcomes.

About AliveDx

AliveDx is driven by its mission to enhance diagnostic understanding, revolutionize patient care, and foster innovation in life sciences. With over three decades of experience in in vitro diagnostics, the company is set on shaping the future of diagnostic solutions across various domains, including autoimmunity and allergy management. Their product portfolio comprises renowned brands like Alba, MosaiQ, and LumiQ, aimed at delivering economic and clinical value to laboratories and clinical settings by improving workflow efficiencies and providing swift, precise results for informed clinical decision-making.

Conclusion

The submission of the MosaiQ AiPlex® Celiac Disease test to the FDA signifies a monumental stride towards innovative healthcare solutions. As AliveDx awaits regulatory approval, the anticipation builds around providing clinicians with advanced diagnostic tools that enhance the accuracy and efficiency of celiac disease diagnosis, ultimately improving the lives of countless patients.