AliveDx has secured CE Mark approval for multiplexed MosaiQ AiPlex Vasculitis (VAS) assay under the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR).
The MosaiQ AiPlex VAS assay is designed to expedite diagnosis of autoimmune vasculitis by delivering quicker results and streamlining laboratory workflows.
It enhances the diagnosis through improved testing of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides and Anti-GBM (Goodpasture’s) disease.
ANCA-associated vasculitides include eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).
The three conditions cause blood vessel inflammation, potentially leading to severe organ damage if untreated.
The CE mark allows the clinical use of MosaiQ AiPlex assay in the EU and other countries accepting the IVDR-CE mark.
AliveDx CEO Manuel Méndez said: “Our MosaiQ technology provides multiplexed test results fully automated and at speed, which shortens time to results and supports accelerated diagnosis of autoimmune diseases, improving patient outcomes and reducing healthcare costs.
“Achieving IVDR-CE Mark approval is a major step forward in our mission to bring best-in-class healthcare solutions to clinicians, labs – and most of all, patients across Europe.
“This milestone confirms our commitment to meeting the highest standards of safety, performance, and quality with yet another panel in our portfolio.”
The MosaiQ platform offers a high-throughput, automated multiplexing capability, combining multiple markers into one test for insights and reduced hands-on time.
Internal calibration of each microarray at manufacture and RFID-tagged reagents further streamline laboratory workflows, saving time and reducing manual errors.
The assay facilitates simplified serological evaluation for healthcare providers.
It leverages only 10μl of patient serum to provide results for three key autoantibody markers, GBM, MPO, and PR3, in a single report.
The markers align with the 2022 ACR/EULAR guidelines for ANCA-associated vasculitis and the KDIGO 2021 guideline for Glomerular Diseases.
MosaiQ solution is an advanced in vitro diagnostic platform for autoimmune diseases and beyond, providing high throughput with continuous random access.
