AliveDx Submits 510(k) Application for MosaiQ AiPlex CTDplus Microarray to FDA

AliveDx Takes a Major Step in Diagnostics with FDA Submission

On April 3, 2025, AliveDx, a pioneering company in the diagnostics sector, made an important announcement regarding its MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) multiplex microarray. The firm has officially submitted a premarket notification, commonly known as a 510(k) application, to the U.S. Food and Drug Administration (FDA). This submission is centered around enhancing diagnostic precision for a range of systemic autoimmune rheumatic diseases—an area that affects millions worldwide.

The Importance of the MosaiQ AiPlex CTDplus Microarray

Prior to this submission, the MosaiQ AiPlex CTDplus multiplex assay received IVDR-CE mark certification in February 2025, positioning it as a significant innovation. This technological advance aims to streamline laboratory workflows while simultaneously increasing the speed and accuracy of diagnosing connective tissue diseases, including but not limited to Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Sjögren's syndrome. The complexity surrounding these conditions often stems from overlapping symptoms and a high rate of co-occurrence, making accurate diagnosis a challenging endeavor for healthcare providers.

Manuel O. Méndez, the CEO of AliveDx, expressed enthusiasm about the submission, noting, "With autoimmune disease diagnoses often taking over four years, there is an urgent need for a multiplexed and syndromic approach that can expedite this process. Our MosaiQ AiPlex CTDplus microarray addresses this critical challenge by facilitating early disease detection and fostering more targeted and effective treatments."

How the MosaiQ AiPlex CTDplus Works

The MosaiQ AiPlex CTDplus has been designed to operate efficiently, providing laboratory professionals with fast and comprehensive testing capabilities. By consolidating multiple relevant markers into a single assay, the technology not only enhances patient care but also significantly reduces hands-on workload and consumable usage within the laboratory context. The microarray is capable of identifying up to 1275 disease markers per hour, underscoring its high throughput potential.

One key feature of the MosaiQ system is its internal calibration and external quality control measures, which simplify the laboratory processes, therefore minimizing potential errors. Each component of the microarray, including all reagents, is equipped with RFID tags to streamline the workflow.

A Comprehensive Diagnostic Tool

The smart design of the MosaiQ AiPlex CTDplus allows healthcare providers to conduct serological evaluations with a syndromic approach. It integrates 15 essential markers in one assay, targeting most autoantibodies recommended by leading clinical guidelines. This allows clinicians to generate actionable insights from just a 10 μl sample, enhancing the speed and accuracy of diagnosis.

Among the included markers are autoantibodies for a variety of conditions and complications, such as CCP, dsDNA, and Sm, to name a few. The ability to detect these simultaneously represents a leap forward in diagnostics that promises to improve patient outcomes significantly.

Looking Ahead

Beyond the current submission for the CTDplus, AliveDx is also pursuing FDA clearance for their MosaiQ AiPlex Celiac Disease microarray. This move signifies AliveDx's dedication to providing clinical and economic value to healthcare customers in the United States, maintaining a vision of innovation within diagnostics.

At its core, AliveDx’s mission revolves around transforming patient care through diagnostic insights and a commitment to quality. As the company looks to the future, the MosaiQ AiPlex CTDplus microarray is a critical step in shaping the landscape of autoimmune diagnostics, proving beneficial not only for laboratories but for patients who require timely and accurate diagnoses.

For more information on AliveDx and its diagnostic solutions, you can visit their official website at www.alivedx.com or connect with them through social media channels like LinkedIn and X.