AliveDx announces FDA 510(k) submission for its MosaiQ AiPlex VAS assay
Multiplex autoantibody test for MPO, PR3, and GBM designed to accelerate diagnosis of autoimmune vasculitis and Goodpasture’s disease
15 Sept 2025Industry news
AliveDx, the global in-vitro diagnostics company that aims to transform patient care, has announces that it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Vasculitis (VAS) assay*.
The MosaiQ AiPlex® VAS multiplex assay, is designed to advance the testing of anti-MPO, anti-PR-3 and anti-GBM for Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides and Anti-GBM (Goodpasture's) disease and improve time to results to support diagnosis of autoimmune vasculitis. The assay is intended to be used on the recent FDA listed Class II 510(k) exempt approved MosaiQ instrument. The equivalent assay has been commercially available in IVDR CE-marking countries since July 2025, following receipt of IVDR certification.
MosaiQ AiPlex® VAS multiplex assay*: Fast, easy, comprehensive
The MosaiQ AiPlex VAS multiplex assay is designed to simultaneously detect three autoantibody markers - MPO, PR3, and GBM - using only 10 µl of patient serum. The assay runs on the MosaiQ instrument and provides a single result report covering all three markers.
These markers are described in the 2022 ACR/EULAR Classification Criteria for ANCA-associated vasculitides¹–³ and the 2021 KDIGO Clinical Practice Guideline for the Management of Glomerular Diseases⁴.
“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.”
The premarket notification follows on from recent achievements of AliveDx, launching over 90 IVD products globally in the past 12 months, including assays designed to provide comprehensive diagnostic insights for Celiac, Connective Tissue Diseases and Vasculitis. This expansive menu will provide critical insights that empower clinicians to support patients’ needs.
*This product is not currently available in the USA, cleared or approved by the U.S. Food and Drug Administration (FDA) for clinical use.