AliveDx has announced the receipt of IVDR-CE mark for its MosaiQ AiPlex® CTDplus multiplex assay, a significant advancement in the diagnosis and management of Systemic Autoimmune Rheumatic Diseases (SARDs). This multiplex assay enables a syndromic approach, streamlining laboratory workflow while delivering rapid, actionable results that assist clinicians and laboratorians in patient diagnosis and management.
Systemic Autoimmune Rheumatic Diseases: A Global Challenge
Systemic Autoimmune Rheumatic Diseases, including Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus, Systemic Sclerosis (Scleroderma), Sjögren’s syndrome, idiopathic inflammatory myopathies, and mixed connective tissue diseases, affect millions worldwide. These conditions are characterized by autoantibody production and present significant diagnostic challenges due to overlapping clinical symptoms and high rates of co-occurrence among connective tissue diseases.
Diagnosing these conditions is particularly complex, often leading to delayed diagnosis from the onset of symptoms. The detection of specific autoantibodies, alongside clinical and laboratory findings, aids clinicians in assessing these disorders. Multiplex testing plays a critical role in providing a comprehensive autoantibody profile, thereby reducing the time to diagnosis and improving patient outcomes.
MosaiQ AiPlex CTDplus Multiplex Assay: Fast, Easy, Comprehensive
The MosaiQ AiPlex CTDplus assay enables a syndromic approach and accurate serological evaluation of Rheumatoid Arthritis (RA) and connective tissue diseases (CTD). By incorporating a unique combination of autoantibody tests, this assay delivers a highly sensitive and specific diagnostic solution, equipping clinicians with actionable insights for enhanced patient care. Notably, it can generate these results using only 10 μl of patient sample in a single step.
Our CTD microarray includes 15 markers within one panel per patient, encompassing the majority of autoantibodies recommended by relevant clinical guidelines (ACR/EULAR). These markers include DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P, SS-A 60 (Ro60), SS-B (La), TRIM21 (Ro52), Jo-1, CENP-B, Scl-70, and RNA Polymerase III, enabling precise and efficient detection.
Advancing Diagnostic Technologies with IVDR-CE Mark Approval
“We are thrilled to receive our fifth Clinical IVDR-CE mark within the last 18 months, showcasing our unwavering commitment to improving patient care,” said Manuel O. Méndez, CEO of AliveDx. “Accurate and early diagnosis is essential for managing complex autoimmune diseases, and our MosaiQ AiPlex CTDplus assay plays a crucial role in supporting laboratorians and clinicians. This milestone is a testament to our team’s dedication to advancing diagnostic technologies and addressing the pressing needs of patients with autoimmune diseases such as RA and CTD. Looking ahead, we aim to expand our diagnostic portfolio by developing a vasculitis and antiphospholipid multiplex solution, further enhancing the detection and management of systemic autoimmune diseases.”
The MosaiQ® System: Simple Workflow, Fast Results, Actionable Insights
MosaiQ is an advanced in vitro diagnostic (IVD) platform designed for autoimmune diseases, allergies, and other complex conditions. This multiplexed, fully automated planar microarray system enables syndromic testing, allowing for comprehensive and efficient disease detection. With high throughput capabilities and continuous random access, MosaiQ delivers fast, accurate results that align with evolving laboratory efficiency standards.
The MosaiQ AiPlex CTDplus solution can rapidly detect and identify up to 1,275 disease markers per hour, significantly improving diagnostic workflows. The system’s seamless microarray-internal calibration, quality control measures, and multi-constituent external quality controls further enhance laboratory efficiency. Additionally, all reagents and multiplex microarray magazines are equipped with RFID tags, minimizing manual errors and ensuring streamlined operations.
Transforming Autoimmune Disease Diagnostics
The IVDR-CE mark approval of the MosaiQ AiPlex CTDplus multiplex assay underscores AliveDx’s commitment to pioneering innovative diagnostic solutions. By offering an efficient, precise, and rapid approach to diagnosing Systemic Autoimmune Rheumatic Diseases, the MosaiQ system empowers healthcare professionals with the tools needed to improve patient outcomes. With a continued focus on expanding its diagnostic offerings, AliveDx is set to redefine the landscape of autoimmune disease diagnostics, enhancing the lives of patients worldwide.
