#USA #FDA Approval #AliveDx #MosaiQ #Eysins

AliveDx Secures FDA Registration for MosaiQ®

AliveDx, a global player in in-vitro diagnostics, recently marked a significant milestone by registering its innovative instrument, MosaiQ®, as a Class II device exempt from premarket notification with the U.S. Food and Drug Administration (FDA). This pivotal development enables clinical laboratories across the United States to utilize the MosaiQ platform for high-throughput multiplex testing, aimed primarily at accelerating the diagnosis of autoimmune diseases and allergies.

Overview of MosaiQ®

MosaiQ is a next-generation, fully automated immunoassay platform designed to streamline workflow and produce rapid, multiplexed results for complex diagnostic conditions. With its unique random access continuous testing capabilities, laboratories can now achieve significant improvements in efficiency and accuracy while reducing operational costs.

Key Features of MosaiQ®

• - Simplified Workflow: The entirely automated process integrates quality control and calibration, reducing manual intervention and the potential for human error. The random access feature allows for the immediate introduction of patient samples and prompt extraction of results, streamlining the laboratory workflow.
• - Rapid Results: The platform facilitates multiple tests from a single low-volume serum sample, delivering the first result in under an hour and subsequent results every 42 seconds for panels.
• - Actionable Insights: Designed for syndromic testing, MosaiQ multiplex panels enhance the detection of comorbidities, assisting clinicians in making informed decisions based on comprehensive data.

Regulatory Milestone

The registration of MosaiQ as a Class II 510(k) exempt device is a crucial endorsement from the FDA, opening avenues for AliveDx to provide its state-of-the-art multiplex testing solutions to healthcare professionals and patients in the United States. Manuel O. Méndez, CEO of AliveDx, expressed his enthusiasm about entering the U.S. market, highlighting the company’s commitment to improving diagnostic information that ultimately enhances patient outcomes.

Clinical Potential

The MosaiQ system boasts a flexible menu of multiplex assays for autoimmune diseases and allergies, crafted from key markers aligned with recommended clinical practices. The panels include:

• - AiPlex® CTDplus: A comprehensive panel for connective tissue diseases, including conditions such as rheumatoid arthritis and systemic lupus erythematosus, all on a single biochip.
• - AiPlex® CD: Focused on celiac disease, this panel combines relevant IgA and IgG markers for efficient diagnostics.
• - AiPlex® VAS: This panel targets vasculitis with three key autoantibody markers on a single biochip.
• - AiPlex® APS: Designed for antiphospholipid syndrome, it offers a set of four combined markers.
• - AllergyPlex® COMBO: This extensive panel assesses up to 34 clinically relevant allergens from one single chip.

Additional panels targeting specific organ-related autoimmune diseases and allergenic materials are also in the pipeline, further expanding the diagnostic capabilities of the MosaiQ platform.

Commitment to Advancement

Following this milestone, AliveDx aims to prepare submissions for the FDA's 510(k) authorization for these assays within the MosaiQ system, continuing their mission to revolutionize diagnostic practices and substantially improve patient care. With over three decades of experience, AliveDx remains dedicated to shaping the future of diagnostics, focusing on autoimmune diseases, allergies, and various other conditions.

For further insight into AliveDx and their in-vitro diagnostic solutions, visit www.alivedx.com or follow them on LinkedIn and X.