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Recent press, briefings and insights help you stay informed about our latest product and solution developments.
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AliveDx announces U.S. Food and Drug Administration (FDA) 510(k) submission for its MosaiQ AiPlex® Vasculitis (VAS) assay.
Eysins, Switzerland, September 2nd, 2025 AliveDx, the global in-vitro diagnostics company that aims to transform patient care, today announces that it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Vasculitis (VAS) assay*. The MosaiQ AiPlex® VAS multiplex assay, is designed to advance the testing of anti-MPO,…
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MosaiQ AiPlex® Vasculitis assay, now available for clinical use in the European Union and other CE mark accepting countries.
AliveDx achieves IVDR-CE Mark for a multiplexed MosaiQ AiPlex® Vasculitis (VAS) assay, designed to advance the testing of Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides and Anti-GBM (Goodpasture’s) disease and improve time to results to support diagnosis of autoimmune vasculitis. Eysins, Switzerland, August 4th, 2025, – AliveDx, the global in vitro diagnostics company that aims to transform…
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AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Celiac Disease (CD) multiplex microarray. The MosaiQ AiPlex CD is designed to improve the accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows
Eysins, Switzerland, February 10th 2025 – AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Celiac Disease (CD) microarray. The MosaiQ AiPlex CD multiplex assay, which received IVDR-CE mark certification in August 2024, is designed to improve the accuracy and speed of celiac disease…
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AliveDx Expands Autoimmune Menu with IVDR-CE Marked MosaiQ AiPlex® CTDplus Multiplex Assay to Aid in Diagnosing Systemic Autoimmune Rheumatic Diseases and Streamline Laboratory Workflow
Eysins, Switzerland February 3rd, 2025 – AliveDx 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…
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AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease (CD) on the MosaiQ® System
Eysins, September 3, 2024 At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. We are excited and proud to announce AliveDx has received IVDR-CE mark certification for its multiplexed MosaiQ AiPlex™ CD microarray immunoassay, designed to improve the accuracy and speed of diagnosing celiac disease. Receiving the IVDR-CE…
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AliveDx Announces Turnkey Solution for Precise, Automated Autoimmune Diagnostics
Eysins Switzerland 29 July 2024 AliveDx, a global in vitro diagnostics company that aims to transform patient care, today announced LumiQ™ – an innovative, automated immunofluorescence assay (IFA) solution. With this portfolio expansion, AliveDx can offer customers a differentiating, turnkey solution for autoimmune diagnostics with LumiQ IFA and groundbreaking MosaiQ® planar microarray technology. “The addition…
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AliveDx Receives IVDR CE Mark for Groundbreaking Microarray Immunoassay in Allergy Diagnostics
Eysins, Switzerland, 29 July 2024 AliveDx is proud to announce it has received IVDR CE mark for its groundbreaking microarray immunoassay, designed for the detection of a specific IgE directed to a protein allergen in human serum. This is the Company’s first product for the evaluation of allergies, enhancing its portfolio of products beyond autoimmunity.…
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AliveDx receives IVDR Certification of its Manufacturing Sites in Switzerland and United Kingdom
Eysins, 6 November 2023 — AliveDx a global in vitro diagnostics company headquartered in Eysins, Switzerland, today announced it has now received IVDR Certification for both its state-of-the-art manufacturing facilities located in Eysins, Switzerland and Edinburgh, United Kingdom. AliveDx is proud to announce its manufacturing facilities have been granted In Vitro Diagnostic Regulation (IVDR) certification…
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AliveDx receives three IVDR CE marks for its Multiplexed Autoimmune Diagnostics Solution
AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD). Eysins, 30 October 2023 — AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray,its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its MosaiQ AiPlex CTD…
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Quotient Limited Selected to Join the World Economic Forum New Champions Community
JERSEY, Channel Islands, September 8th 2022 (GLOBE NEWSWIRE) — Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company (Quotient), headquartered in Eysins, Switzerland, today announced it was selected by the World Economic Forum to join their New Champions Community. “We are delighted to welcome Quotient Limited as part of the New Champions Community,” said Julia Devos, Head…
