#USA #AliveDx #MosaiQ AiPlex #Celiac Disease #Eysins, Switzerland

AliveDx Seeks FDA Approval for New Celiac Disease Test

AliveDx, a company focused on advancements in diagnostic solutions, has made significant strides by submitting its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Celiac Disease multiplex microarray. This innovative test aims to enhance the accuracy and speed of diagnosing celiac disease, a chronic autoimmune condition affecting millions globally.

Understanding Celiac Disease

Celiac disease is characterized by an abnormal immune response to gluten, a protein found in wheat, barley, and rye. The prevalence of this disorder is approximately 1 in 100 worldwide, with symptoms that can range widely, often complicating timely diagnoses. For those predisposed, the consumption of gluten can lead to the formation of autoantibodies and damage to the small intestine.

The Need for Efficient Diagnostics

The average time from the onset of symptoms to a definitive celiac disease diagnosis often exceeds four years. The introduction of the MosaiQ AiPlex CD multiplex assay is designed to bridge this gap and provide healthcare providers with a syndromic approach to testing. With just a 20 μl patient sample, the test can simultaneously analyze five critical markers, significantly streamlining laboratory workflows and enhancing patient care.

Features of the MosaiQ AiPlex CD Assay

The MosaiQ AiPlex CD multiplex assay was awarded IVDR-CE certification in August 2024, positioning it as a reliable diagnostic tool. Key features include:

• - Syndromic Testing: This allows for both inclusion and exclusion of celiac disease based on a comprehensive assessment.
• - Comprehensive Analysis: The test integrates both IgA and IgG isotypes, enabling a holistic view of each patient's situation.
• - Rapid Results: Designed for high throughput, it can process up to 425 disease markers per hour, presenting results faster than traditional methods.
• - User-Friendly Workflow: The system’s automation minimizes manual errors and reduces the reliance on consumable materials, thereby promoting efficiency and cost-effectiveness.

CEO Manuel O. Méndez expressed excitement about the submission, stating, “Our MosaiQ AiPlex CD solution fulfills the urgent need for a multiplex approach in accelerating the diagnosis of celiac disease, enabling quicker treatment interventions that provide patients with the relief they desperately need.”

Innovations for Future Diagnostics

AliveDx is committed to redefining diagnostic processes with its cutting-edge IVD solutions that cater to autoimmune diseases, allergies, and more. The MosaiQ platform serves as a point of transformation within laboratories, enhancing efficiency while delivering precise and actionable insights. By leveraging RFID technology in reagents and microarray cassettes, AliveDx seeks to eradicate the possibility of human error and ensure a seamless laboratory experience.

Live Dx's endeavors encapsulate over three decades of experience in the in-vitro diagnostics field, and they have continuously transformed how healthcare providers conduct tests and make decisions based on results.

To learn more about AliveDx and its revolutionary IVD solutions, visit www.alivedx.com and connect with them on LinkedIn and X.