AliveDx Advances MosaiQ Platform in US Market with FDA Device Registration and Vasculitis Test Submission
核心洞察
AliveDx (搜索) has registered its MosaiQ (搜索) instrument with the FDA as a Class II 510(k) exempt medical device, enabling US clinical laboratories to adopt the multiplexed autoimmune and allergy testing platform.
The MosaiQ (搜索) system delivers comprehensive results from a single low-volume serum sample, with time-to-first patient result under one hour and consecutive panel results every 42 seconds.
The company has submitted a 510(k) premarket notification to the FDA for its MosaiQ (搜索) AiPlex Vasculitis (搜索) test, designed to aid in diagnosing rare autoimmune diseases (搜索) that cause blood vessel inflammation.
AliveDx (搜索), a global in-vitro diagnostics company, has achieved a significant regulatory milestone with the FDA registration of its MosaiQ (搜索) instrument as a Class II 510(k) exempt medical device, marking the company's entry into the US market for multiplexed autoimmune and allergy testing. The Swiss-based company announced on August 26, 2025, that this registration authorizes the use of MosaiQ in US clinical laboratories, enabling adoption of what the company describes as a next-generation, continuous random-access immunoassay platform.
Advanced Multiplexing Technology
The MosaiQ (搜索) solution represents a fully automated planar microarray platform designed for syndromic testing of complex conditions. The system combines high throughput capabilities with continuous random access, delivering what AliveDx (搜索) characterizes as fast and accurate results to address evolving laboratory efficiency expectations.
Key performance specifications include a time-to-first patient result under one hour and consecutive patient panel results delivered every 42 seconds. The platform processes multiple tests from a single low-volume serum sample, incorporating built-in quality control and calibration features designed to lower costs and increase laboratory efficiency through a patient sample in, result out workflow.
"We're excited to enter the U.S market with our disruptive MosaiQ (搜索) instrument," said Manuel O. M. Méndez, CEO of AliveDx (搜索). "This effort underscores our continued commitment in partnering with laboratories and clinicians to gain diagnostic insights which ultimately enables improved patient outcomes."
Comprehensive Assay Portfolio
The MosaiQ (搜索) system offers a flexible menu of multiplex assays targeting autoimmune diseases (搜索) and allergies (搜索), designed with key markers according to recommended clinical guidelines. The planned assay portfolio includes:
AiPlex CTDplus (搜索) features a comprehensive 15-marker panel for connective tissue diseases (搜索) including rheumatoid arthritis (搜索), systemic lupus erythematosus (搜索), Sjögren's syndrome (搜索), and systemic sclerosis (搜索) on a single microarray.
AiPlex CD (搜索) provides celiac disease (搜索) testing through a 5-marker panel combining IgA and IgG markers on one microarray.
AiPlex VAS (搜索) targets vasculitis (搜索) diagnosis with a 3-marker panel including key autoantibody markers MPO (搜索), PR3 (搜索), and GBM (搜索) on one microarray.
AiPlex APS (搜索) addresses antiphospholipid syndrome (搜索) through a 4-marker panel combining both IgM and IgG markers on one microarray.
AllergyPlex COMBO (搜索) covers up to 34 markers designed to address the most clinically relevant allergens on one microarray.
Regulatory Pathway Forward
Following the instrument registration milestone, AliveDx (搜索) has initiated the regulatory process for individual assays. On September 3, 2025, the company submitted a 510(k) premarket notification to the FDA for its MosaiQ (搜索) AiPlex Vasculitis (搜索) test, designed to aid in diagnosing vasculitis, described as a group of rare autoimmune diseases (搜索) that cause inflammation of blood vessels.
The company indicated that additional panels targeting organ-specific autoimmune diseases (搜索) and more specific allergy components are in development. AliveDx (搜索) stated it will focus on preparing submissions to the FDA seeking 510(k) clearance for these assays on the MosaiQ (搜索) system, though specific timelines for FDA review or market availability were not disclosed.
Clinical Laboratory Impact
The MosaiQ (搜索) platform addresses laboratory workflow challenges through what AliveDx (搜索) describes as actionable insights delivered via multiplex panels designed to support syndromic testing, detect comorbidities, and streamline clinical decision-making with comprehensive insights. The fully automated process aims to enable laboratories to deliver faster, more comprehensive results in autoimmune and allergy testing compared to traditional single-analyte approaches.
AliveDx (搜索), with over 30 years in in-vitro diagnostics, positions the MosaiQ (搜索) advancement as part of its mission to empower diagnostic insights and transform patient care in autoimmune, allergy, and related diagnostic areas.