AliveDx’s MosaiQ AiPlex CTDplus Assay Earns IVDR-CE Mark for AIIRD

AliveDx, a company that develops in-vitro diagnostic solutions to help patients get diagnosed and treated faster, announces the receipt of IVDR-CE mark for its MosaiQ AiPlex CTDplus multiplex assay. The multiplex assay enables a syndromic approach, simplifying laboratory workflow while delivering fast, actionable results to aid clinicians and laboratorians with the patient diagnosis and management of systemic autoimmune rheumatic diseases (SARDs).

Systemic autoimmune rheumatic diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus, systemic sclerosis (also known as scleroderma), Sjögren’s syndrome, idiopathic inflammatory Myopathies and mixed connective tissue diseases affect millions worldwide and are associated with autoantibody production.

Diagnosing these conditions is complex due to overlapping clinical symptoms and high rates of co-occurrence among a range of connective tissue diseases. This complexity often leads to delayed diagnosis from symptom onset. The detection of various autoantibodies, along with clinical and other laboratory findings, assists clinicians in assessing these disorders. Multiplex testing provides a comprehensive autoantibody profile and helps reducing time to diagnosis.

The MosaiQ AiPlex CTDplus assay enables a syndromic approach and accurate serological evaluation of rheumatoid arthritis (RA) and connective tissue diseases (CTD) for healthcare providers. Its unique combination of autoantibody tests offers a sensitive and specific diagnostic solution, assisting clinicians with actionable insights for improved patient care. It can generate these results with only 10 µl patient in one single step.

Our CTD microarray includes 15 markers in one panel for each patient, including the majority of autoantibodies recommended by the relevant clinical guidelines (ACR/EULAR). The MosaiQ AiPlex CTDplus features the simultaneous detection of autoantibodies directed to 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.

“We are excited to receive our fifth Clinical IVDR-CE mark in the last 18 months. It shows our commitment to enable improved patient care. Accurate and early diagnosis is essential for managing complex autoimmune diseases, and our MosaiQ AiPlex CTDplus assay supports laboratorians and clinicians in achieving this,” said Manuel O. Méndez, CEO of AliveDx. “This milestone reflects our team’s dedication to advancing diagnostic technologies and addressing the significant needs of patients with autoimmune diseases such as RA and CTD. Looking ahead, we plan to expand our offering with a vasculitis and antiphospholipid multiplex solution to enhance the diagnosis of systemic autoimmune diseases.”

The MosaiQ is a state-of-the-art IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex conditions. This intuitive platform offers high throughput with continuous random access, delivers fast and accurateresults addressing evolving expectations for laboratory efficiency. It can rapidly detect and identify up to 1,275 disease markers per hour for the MosaiQ AiPlex CTDplus solution. Seamless, microarray-internal calibration and quality control as well as multi-constituent, external quality controls further help simplify laboratory workflow. All reagents and multiplex microarray magazines are equipped with RFID tags to save time while avoiding manual errors.

AliveDx’s mission is to empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, the company is dedicated to shaping the future of global diagnostics in autoimmune, allergy, and beyond.

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