AliveDx's Innovative MosaiQ AiPlex Aims to Transform Celiac Disease Diagnosis in the U.S.

AliveDx Submits FDA 510(k) for Revolutionary Celiac Disease Diagnostic Tool

In a significant advancement for patients with celiac disease, AliveDx has announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative MosaiQ AiPlex® multiplex microarray for diagnosing celiac disease (CD). This development comes on the heels of the assay's IVDR-CE mark certification received in August 2024, highlighting its readiness for clinical application.

Celiac Disease: An Overview

Celiac disease is a chronic autoimmune disorder that affects approximately 1 in 100 individuals globally, primarily impacting the small intestine. This condition arises when genetically susceptible individuals consume gluten, leading to an immune response that damages the small bowel and produces a range of autoantibodies. The symptoms often manifest in multiple organs, creating a complex diagnostic challenge for healthcare providers. Diagnosing this condition can take an average of four years, emphasizing the urgent need for rapid and accurate testing solutions.

The MosaiQ AiPlex Advantage

The MosaiQ AiPlex CD multiplex assay is designed to streamline and enhance the diagnostic process for celiac disease. The assay employs a syndromic approach, pooling multiple diagnostic markers into one singular process. Specifically, it combines IgA and IgG isotypes, requiring only a 20 μl sample from the patient. This not only eases the testing burden but also offers comprehensive analytical data with remarkable sensitivity and specificity.

With its unique design, the MosaiQ AiPlex CD microarray tests for five critical markers in one panel—thus aligning with the latest clinical guidelines from leading organizations such as the European Society for the Study of Coeliac Disease (ESsCD) and the American College of Gastroenterology (ACG). An important feature of this assay is its ability to detect IgA deficiency, a condition that is prevalent in up to 15 times higher rates among celiac patients, further enhancing diagnostic accuracy for this population.

Simplifying Laboratory Workflows

One of the standout features of the MosaiQ AiPlex CD assay is its capability to perform rapid and reliable testing, processing up to 425 disease markers per hour. This efficiency is crucial in busy clinical settings where time is of the essence. The technology incorporates seamless internal calibration and robust quality control measures, making it adaptable for various laboratory environments.

In addition, the automated multiplex microarray system minimizes hands-on time and reduces the consumption of reagents, significantly lowering operational costs while improving turnaround times. The incorporation of RFID tags on all reagents and microarray magazines minimizes manual errors and further streamlines the workflow.

Moving Forward

Manuel O. Méndez, CEO of AliveDx, expressed enthusiasm about this FDA submission, stating, "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 treatments, offering much-needed relief to patients."

This FDA application marks a pivotal moment for AliveDx as it strives to bring revolutionary diagnostic solutions to market, enhancing patient care and advancing laboratory efficiency. The prospective approval of the MosaiQ AiPlex CD microarray could transform the landscape of celiac disease diagnosis in the U.S.

About AliveDx

Founded with a mission to empower diagnostic insights, AliveDx boasts over 30 years of expertise in in-vitro diagnostics. The company’s commitment lies in innovating for life through solutions that improve diagnosis for various autoimmune conditions and allergies, allowing for faster, more efficient patient care. Their portfolio, including the MosaiQ and LumiQ brands, reflects a dedication to enhancing both clinical outcomes and operational efficiencies in healthcare environments.

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

Conclusion: AliveDx's MosaiQ AiPlex® microarray holds great promise for celiac disease diagnosis by providing a fast, reliable, and user-friendly solution for healthcare providers, ultimately paving the way for improved patient outcomes in this widespread autoimmune disorder.