Novel Multiplex Assay Supports Diagnosis of Autoimmune Vasculitis

Autoimmune vasculitis and related conditions are difficult to diagnose quickly and accurately, often requiring multiple tests to confirm the presence of specific autoantibodies. Traditional methods can be time-consuming, causing delays in initiating treatment and increasing patient anxiety. Now, a new multiplex assay can simultaneously detect multiple markers, offering faster, more comprehensive diagnostic insights for autoimmune vasculitis.

AliveDx’s (Vaud, Switzerland) MosaiQ AiPlex Vasculitis (VAS) assay is designed to detect three key autoantibody markers—MPO, PR3, and GBM—from just 10 µl of patient serum. The assay is intended to be used on the MosaiQ instrument, which recently received its own FDA Class II 510(k) exempt approval. The multiplex assay provides a single report covering all markers, streamlining workflows while aligning with international diagnostic guidelines.

AliveDx has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its MosaiQ AiPlex Vasculitis (VAS) assay, building on its earlier rollout in CE-marked regions, where it has already been in clinical use since July 2025. The system has demonstrated the ability to deliver comprehensive results that cover all three markers cited in the 2022 ACR/EULAR Classification Criteria for ANCA-associated vasculitides and the 2021 KDIGO Clinical Practice Guideline for glomerular diseases.

AliveDx has launched over 90 IVD products globally in the past year, adding assays for autoimmune diseases like celiac disease and connective tissue disorders. The MosaiQ AiPlex VAS assay adds to this growing menu, offering clinicians greater efficiency and faster results in diagnosing complex conditions. With FDA review underway, the company plans to expand the MosaiQ portfolio in the U.S., further supporting clinicians with comprehensive autoimmune diagnostic solutions.

“Submitting the 510(k) premarket notification to the FDA for our MosaiQ AiPlex VAS microarray is an important step in advancing innovative diagnostic solutions for clinicians and patients in the U.S,” said Manuel O. Méndez, CEO of AliveDx. “Globally, AliveDx and our partners are advancing our goal to deliver solutions that provide greater clinical and economic value, ultimately aiming to improve patient outcomes.”

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