AliveDx has announced that its MosaiQ AiPlex CTDplus multiplex assay for the diagnosis and management of systemic autoimmune rheumatic diseases (SARDs) has received the IVDR-CE mark
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 SARDs.
These diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), systemic sclerosis (also known as scleroderma), Sjögren’s syndrome, idiopathic inflammatory myopathies and mixed connective tissue disease CTD) 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 reduce time to diagnosis.
The MosaiQ AiPlex CTDplus assay enables a syndromic approach and accurate serological evaluation of RA and 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 from a 10 μL sample in one single step.
AliveDx’s CTD microarray includes 15 markers in one panel for each patient, including the majority of autoantibodies recommended by the relevant clinical guidelines.
“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 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 (pictured above) 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 accurate results 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.