#AliveDx #MosaiQ #AiPlex

AliveDx Submits 510(k) Application for MosaiQ AiPlex® CTDplus

AliveDx, a leader in diagnostic solutions, has announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® multiplex microarray. This innovative test is designed specifically for the diagnosis of connective tissue diseases (CTDs), aiming to enhance both accuracy and speed in the diagnostic workflow.

About the MosaiQ AiPlex® CTDplus Test

The MosaiQ AiPlex CTDplus test is a multiplex assay that holds immense potential for diagnosing complex autoimmune conditions, such as rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis, which affect millions globally. These diseases are characterized by the production of autoantibodies, rendering diagnosis particularly challenging due to overlapping clinical symptoms and high rates of comorbidities.

With the MosaiQ AiPlex CTDplus, healthcare professionals can identify up to 1,275 disease markers within just one hour. This ability significantly reduces laboratory flow times, ultimately leading to quicker patient results and enhanced care. Packed with advanced RFID tagging for all reagents and multiplex microarray cartridges, this system ensures efficiency and minimizes errors that often arise from manual handling.

Innovative Approach to Diagnosis

This multiplex solution facilitates a syndromic approach for healthcare providers, offering a serological assessment critical for conditions like arthritis and CTDs. Its unique configuration allows for the simultaneous detection of numerous autoantibodies, streamlining the entire diagnostic process for clinicians. The test requires only a small sample size of 10 μl, providing detailed results within a single operational step.

The MosaiQ AiPlex CTDplus includes 15 distinct markers associated with major clinically recommended autoantibodies, including anti-CCP, anti-dsDNA, and anti-Scl-70, among others. This extensive panel provides clinicians with the practical insight necessary for informed decision-making and targeted treatment plans.

A Game Changer for Patient Care

Manuel O. Méndez, CEO of AliveDx, emphasized the pressing need for innovative diagnostic measures, stating, “We are pleased to present the MosaiQ AiPlex® CTDplus to the FDA for 510(k) approval. The time it takes to diagnose autoimmune diseases can stretch beyond four years, and our multiplexed approach aims to change that reality, enabling earlier disease detection and supporting more effective and specific treatment plans.