AliveDx's MosaiQ® Platform Registered with FDA as Class II 510(k) Exempt, Enabling US Labs to Adopt High-Throughput Automated Immunoassay Testing
MosaiQ is a next-gen immunoassay platform delivering automated, multiplexed testing and actionable insights for complex conditions
Eysins, Switzerland — August 25, 2025 — AliveDx, the global in-vitro diagnostics company dedicated to advancing patient care, today announced that its MosaiQ® instrument is registered with the U.S. Food and Drug Administration (FDA) as a Class II 510(k) exempt medical device. This marks a significant milestone for clinical laboratories in the United States, enabling adoption of a multiplexing, high-throughput, automated testing platform designed to deliver faster, more comprehensive results in autoimmune and allergy testing.
About the MosaiQ solution
The MosaiQ solution is a next-generation IVD solution for autoimmune diseases, allergies, and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex conditions. Designed with ease-of-use in mind, MosaiQ combines high throughput with continuous random access and delivers fast and accurate results addressing evolving expectations for laboratory efficiency.
Key benefits include:
Simple workflow
Fully automated process with built-in QC and calibration lowering costs and increasing laboratory efficiency. Continuous random access enables patient sample in, result out in one single step.
Fast results
Multiple tests from a single low-volume serum sample, with time-to-first patient result under one hour and consecutive patient panel results every 42 seconds.
Actionable insights
Multiplex panels designed to support syndromic testing, detect comorbidities, and streamline decision-making for clinicians with comprehensive insights.
Regulatory milestone
The listing as a Class II 510(k) exempt medical device, authorizes the use of MosaiQ in US clinical labs—a milestone that enables AliveDx to bring its innovative multiplexing system to clinicians and patients in the US.
“We’re excited to enter the U.S market with our disruptive MosaiQ instrument” said Manuel O. Méndez, CEO of AliveDx. “This effort underscores our continued commitment in partnering with laboratories and clinicians to gain diagnostic insights which ultimately enables improved patient outcomes.”
MosaiQ Assays*
The MosaiQ system has the potential to offer a flexible menu of multiplex assays for autoimmune diseases and allergies, designed with key markers as per recommended clinical guidelines for:
- AiPlex® CTDplus* — A comprehensive panel (15 markers) for connective tissue diseases (e.g., RA, SLE, Sjögren’s, SSc) on one microarray.
- AiPlex® CD* — Celiac disease panel (5 markers) combining IgA and IgG markers on one microarray.
- AiPlex® VAS* — Vasculitis panel (3 markers), key autoantibody markers – MPO, PR3, and GBM on one microarray.
- AiPlex® APS** — Antiphospholipid Syndrome panel (4 markers) combining both IgM and IgG markers on one microarray.
- AllergyPlex® COMBO** — Up to 34 markers designed to cover the most clinically relevant allergens on one microarray.
- Additional panels targeting organ specific autoimmune diseases and more specific allergy components, and others are in development.
*These assays are not available for clinical testing purposes in the US, subject to U.S. FDA 510(k) clearance.
**These assays are not available for clinical testing purposes, subject to IVDR CE-mark and U.S. FDA 510 (k) clearance.
Following this important milestone, AliveDx will focus on preparing submissions to the U.S. Food and Drug Administration seeking 510(k) clearance for these assays on the MosaiQ system.