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AliveDx's Milestone in Autoimmune Disease Diagnostics

In a groundbreaking announcement on April 3, 2025, AliveDx shared its plans to enhance the diagnostic landscape for autoimmune diseases by submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its multiplex biochip, MosaiQ AiPlex® CTDplus. Designed to streamline laboratory workflows and bolster diagnostic precision, this innovative testing solution has already garnered the IVDR-CE mark in February 2025, reinforcing its readiness for clinical application.

An Answer to Complex Autoimmune Diagnoses

The MosaiQ AiPlex CTDplus is engineered to tackle the complexities associated with diagnosing systemic autoimmune rheumatic diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (scleroderma), and mixed connective tissue diseases. These conditions are challenging to diagnose due to overlapping clinical symptoms and the frequent co-occurrence of multiple autoantibodies, affecting millions worldwide.

According to recent studies, the journey to an accurate diagnosis for such conditions can often extend beyond four years. Recognizing this challenge, AliveDx has developed a solution that not only expedites diagnosis but also empowers clinicians to make informed clinical decisions more swiftly and efficiently.

Features of the MosaiQ AiPlex CTDplus

High Throughput and Simplicity

The MosaiQ AiPlex CTDplus offers a sophisticated multiplex testing capability that allows laboratories to detect and identify up to 1,275 disease markers per hour. This high throughput is achieved thanks to the innovative design that integrates multiple relevant markers into a single assay, significantly reducing the time required for laboratory processing, while also minimizing consumable use.

One standout feature of the MosaiQ platform is its automation and internal quality control mechanisms, designed to streamline laboratory workflows and improve diagnostic accuracy. Each assay component is tagged with RFID technology, which not only enhances efficiency but also mitigates the risk of human error.

Comprehensive Testing Capabilities

The multiplex biochip accommodates a unique panel comprising 15 markers that are critical for diagnosing conditions like RA and other systemic connective tissue diseases. The range of autoantibodies identified includes those against DFS70/LEDGF, CCP, dsDNA, and Sm, aligning with clinical guidelines set forth by major rheumatology associations. Remarkably, this biochip can generate test results from just a 10μl patient sample in a single step, representing a significant leap forward in serological evaluations.

Value Proposition for Healthcare Providers

Manuel O. Méndez, CEO of AliveDx, emphasized the importance of this milestone, stating, “We are thrilled to submit the 510(k) application for the MosaiQ AiPlex CTDplus to the FDA. Accelerating the diagnosis of autoimmune diseases is not just beneficial; it is imperative in offering timely and targeted treatments to patients.” This sentiment reflects AliveDx’s commitment to enhancing patient outcomes through innovative diagnostic solutions.

About AliveDx

Established over three decades ago, AliveDx is dedicated to pioneering advancements in diagnostic knowledge and transforming patient care. With a focus on in vitro diagnostics, the company aims to reshape the future of healthcare in autoimmunity and allergies. Their product offerings include the well-regarded MosaiQ and LumiQ brands, which are designed to provide economic and clinical value while enhancing laboratory efficiency and accelerating decision-making processes in patient care.

For further information about AliveDx and their innovative diagnostic solutions, please visit alivedx.com and stay connected through their LinkedIn and X social media channels.

Conclusion

The introduction of the MosaiQ AiPlex CTDplus is a significant advancement in the realm of autoimmune diagnostics. By integrating cutting-edge technology with streamlined processes, AliveDx is not only addressing a critical need in the healthcare sector but also setting a new standard for diagnostic accuracy and efficiency in the industry.