AliveDx gains IVDR CE mark for MosaiQ AiPlex CTDplus assay

Original from: Medical Device Network

AliveDx has obtained a CE mark under the EU’s in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease (CTDplus) multiplex assay for use with its MosaiQ planar microarray platform.

The Swiss company’s assay for the detection of Systemic Autoimmune Rheumatic Diseases (SARDs/CTDs) such as systemic lupus erythematosus (SLE), rheumatoid arthritis, and scleroderma is designed to simplify the detection and assessment of various autoantibodies related to CTDs and help reduce clinicians’ time towards diagnosis.

Research indicates that diagnosing CTDs is complex due to overlapping clinical symptoms and high rates of co-occurrence among a range of CTDs. This complexity often leads to delayed diagnosis.

AiPlex CTDplus enables a syndromic approach to CTD diagnosis and includes 15 markers in one panel for each patient that covers the majority of autoantibodies recommended by the relevant clinical guidelines.

With simultaneous detection of autoantibodies directed to a range of proteins and nucleic acids, AliveDx stated that the assay can generate results from 10μl (microlitres) per patient in a single step.

AliveDx CEO Manuel O Méndez commented: “We are excited to receive our fifth clinical IVDR CE mark in the last 18 months.

“Accurate and early diagnosis is essential for managing complex autoimmune diseases, and our MosaiQ AiPlex CTDplus assay supports laboratorians and clinicians in achieving this.”

AliveDx previously gained CE marks for assays including the MosaiQ Centromere Protein B (CENP-B) microarray for the identification of autoantibodies to Centromere Protein B, and MosaiQ AiPlex CD for diagnosing celiac disease.

Méndez added: “Looking ahead, we plan to expand our offering with a vasculitis and antiphospholipid multiplex solution to enhance the diagnosis of systemic autoimmune diseases.”

Other companies involved in the development of autoantibody testing kits for SARDs identification include Bio-Rad Laboratories, bioMerieux SA, and Beckman Coulter.

Source: AliveDx gains IVDR CE mark for MosaiQ AiPlex CTDplus assay