The automated immunoassay platform offers continuous random access testing for autoimmune diseases and allergies with results in under one hour.
AliveDx has registered its MosaiQ instrument with the FDA as a Class II 510(k) exempt medical device, marking the Swiss company’s entry into the US clinical laboratory market with its multiplexed testing platform for autoimmune diseases and allergies.
The registration enables US clinical laboratories to adopt the next-generation immunoassay platform, which combines high-throughput automation with continuous random access capabilities. The system delivers time-to-first patient results in under one hour and consecutive patient panel results every 42 seconds using low-volume serum samples.
“We’re excited to enter the US market with our disruptive MosaiQ instrument,” says Manuel O Méndez, CEO of AliveDx, in a release. “This effort underscores our continued commitment in partnering with laboratories and clinicians to gain diagnostic insights which ultimately enables improved patient outcomes.”
Platform Features Target Laboratory Efficiency
The MosaiQ solution uses a fully automated planar microarray platform designed for syndromic testing of complex conditions. The system incorporates built-in quality control and calibration functions in a single-step workflow that processes patient samples from input to result output.
Key operational benefits include multiple tests from single serum samples, continuous random access processing, and multiplex panels designed to detect comorbidities and support clinical decision-making. The platform aims to reduce laboratory costs while increasing efficiency through its automated processes.
The system’s multiplexing capabilities enable laboratories to run comprehensive panels for autoimmune diseases and allergies, addressing clinical guidelines for various conditions through a single testing workflow.
Assay Development Pipeline Awaits FDA Clearance
While the instrument registration allows US laboratories to acquire the MosaiQ platform, the company’s assay menu requires separate FDA 510(k) clearance before clinical use. AliveDx plans to submit applications for various multiplex assays covering autoimmune diseases and allergies following this regulatory milestone.
The company has not disclosed specific timelines for assay submissions or expected clearance dates. Current assay development focuses on panels aligned with clinical guidelines for autoimmune and allergy testing applications.
AliveDx, which has over 30 years of experience in in-vitro diagnostics, operates globally with a portfolio that includes Alba, MosaiQ, and LumiQ brands. The company is based in Eysins, Switzerland, and focuses on autoimmune, allergy, and related diagnostic applications.
Photo caption: MosaiQ Multiplex Testing Platform
Photo credit: AliveDx
