Shots:
- The US FDA has received 510(k) premarket notification for MosaiQ AiPlex Vasculitis (VAS) assay to improve & accelerate diagnosis of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides & Anti-GBM (Goodpasture’s) disease; available in IVDR CE-marking countries since Jul 2025
- VAS assay diagnoses autoimmune vasculitis using just 10μL of sample in a single test, with 3 key autoantibody markers: MPO, PR3, & GBM
- VAS assay allows accurate serological evaluation with rapid results, detecting multiple relevant markers with RFID-tagged reagents & magazines, accelerating the process to reduce time, consumables, & errors while improving calibration, quality control, & lab efficiency
Ref: AliveDx | Image: AliveDx | Press Release
Related News:- AliveDx Receives the CE Mark Approval for MosaiQ AiPlex VAS Assay to Diagnose Autoimmune Vasculitis
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