#USA #FDA Approval #AliveDx #Eysins #MosaiQ AiPlex

AliveDx Achieves New Milestone with FDA Submission for MosaiQ AiPlex® Vasculitis Assay

On September 3, 2025, AliveDx, a leading global in-vitro diagnostics company, made a significant announcement regarding its efforts to transform patient care. The company revealed that it has filed a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) for its MosaiQ AiPlex® Vasculitis (VAS) assay. This assay is designed to enhance the diagnosis process for patients experiencing autoimmune vasculitis, a group of diseases that can be challenging to identify.

Enhancements in Autoimmune Diagnostics

The MosaiQ AiPlex® VAS multiplex assay aims to streamline the testing of three critical autoimmune antibodies: Anti-MPO, Anti-PR3, and Anti-GBM. These markers are essential in diagnosing ANCA-associated vasculitides, a category of conditions that can lead to severe complications if not detected promptly. AliveDx's assay enables healthcare providers to obtain results faster, ultimately leading to timely diagnoses and improved patient management.

The assay is intended for use with the MosaiQ device, a device that has recently been cleared by the FDA. Since its introduction, it has already started gaining traction in markets across regions with IVDR-CE marking, showcasing the growing acceptance of AliveDx’s innovative solutions in the diagnostic landscape.

The Significance of 510(k) Submission

Manuel O. Méndez, the CEO of AliveDx, expressed the importance of the 510(k) submission: "Submitting the premarket notification for our MosaiQ AiPlex VAS assay is a pivotal step toward delivering innovative diagnostic solutions for physicians and patients in the U.S. Our goal is to provide solutions that offer greater clinical and economic value while ultimately improving patient outcomes."

In the last year, AliveDx has introduced more than 90 in-vitro diagnostic products worldwide, including assays that provide crucial insights for conditions such as celiac disease, connective tissue diseases, and vasculitis. This extensive portfolio underscores AliveDx's commitment to advancing diagnostic capabilities that empower clinicians to better serve their patients.

A Closer Look at the MosaiQ AiPlex® VAS Assay

The MosaiQ AiPlex® VAS multiplex assay is designed for efficiency and efficacy. It allows simultaneous detection of three autoantibody markers using only 10 microliters of patient serum. This method not only simplifies the testing process but also condenses the reporting into a single document that covers all three markers, enhancing the workflow for healthcare professionals.

These markers comply with the ACR/EULAR classification criteria for ANCA-associated vasculitides established in 2022 and are referenced in the KDIGO clinical practice guidelines for treating glomerular diseases from 2021. The alignment with established clinical criteria underscores the assay's potential significance in everyday clinical practice.

About AliveDx

With over 30 years of experience in the field of in-vitro diagnostics, AliveDx is dedicated to gaining diagnostic insights that can elevate patient care. The company emphasizes the creation of innovations that not only expedite diagnoses but also improve patient quality of life while ensuring a sustainable work environment for healthcare providers. Its brands, including Alba, MosaiQ, and LumiQ, are focused on generating both clinical and economic benefits through simplified laboratory operations and the delivery of rapid, accurate results that enhance clinical decision-making.

For more information about AliveDx and its in-vitro diagnostic solutions, you can visit their website at www.alivedx.com and follow them on LinkedIn and X. AliveDx continues to push the boundaries of innovation in diagnostics, striving to improve outcomes for patients and healthcare systems alike.