AliveDx announces U.S. Food and Drug Administration (FDA) 510(k) submission for its MosaiQ AiPlex® Vasculitis (VAS) assay.

USA - English

• USA - English
• USA - Deutsch
• USA - Français

EYSINS, Switzerland, Sept. 3, 2025 /PRNewswire/ -- AliveDx, the global in-vitro diagnostics company that aims to transform patient care, today 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 vasculitides^[1]-[3] and the 2021 KDIGO Clinical Practice Guideline for the Management of Glomerular Diseases^[4].

"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. 

About the MosaiQ^® solution 

The MosaiQ solution is a state-of-the-art IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex conditions. This intuitive platform offers high throughput with continuous random access, delivers fast and accurate results addressing evolving needs and expectations for laboratory efficiency. 

About AliveDx   

At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we are dedicated to shaping the future of global diagnostics in autoimmune, allergy, and beyond. Our groundbreaking solutions empower laboratories and clinicians to accelerate diagnosis, improving patients' lives while fostering a positive and sustainable work environment for healthcare providers. Our portfolio includes the Alba, MosaiQ and LumiQ brands. These solutions aim to generate both economic and clinical value by simplifying laboratory workflows and providing fast, accurate results that enhance clinical decision-making. At AliveDx, we innovate for life.   

For more information about AliveDx and its IVD solutions, please visit www.alivedx.com and connect with us on LinkedIn and X.  

©AliveDx Suisse SA. 2025. The AliveDx logo, AliveDx, MosaiQ and MosaiQ AiPlex, are trademarks or registered trademarks of AliveDx group companies in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories.

1. Robson JC et al. 2022 ACR/EULAR GPA Classification Criteria.Ann Rheum Dis. 2022;81(3):315–320.   
2. Suppiah R et al. 2022 ACR/EULAR MPA Classification Criteria.Ann Rheum Dis. 2022;81(3):321-326.   
3. Grayson PC et al. 2022 ACR/EULAR EGPA Classification Criteria.Ann Rheum Dis. 2022;81(3):309-314.   
4. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276.   

Logo: https://mma.prnewswire.com/media/2657402/5489172/AliveDx_Logo.jpg