AliveDx Takes Significant Steps with FDA Submission for MosaiQ AiPlex® Vasculitis Assay
AliveDx Paves the Way for Improved Vasculitis Diagnostics
EYSINS, Switzerland, Sept. 3, 2025 - AliveDx, a prominent player in the in-vitro diagnostics sector, has announced a monumental step towards enhancing patient care by submitting a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative MosaiQ AiPlex® Vasculitis (VAS) assay. This new diagnostics tool harbors the potential to significantly optimize the detection and management of autoimmune vasculitides.
The MosaiQ AiPlex® VAS assay is a multiplex diagnostic test engineered to identify three vital autoantibody markers—the myeloperoxidase (MPO), proteinase 3 (PR3), and glomerular basement membrane (GBM) antibodies. These markers are essential for diagnosing various autoimmune diseases, particularly those associated with ANCA (anti-neutrophil cytoplasmic antibodies), along with Goodpasture's disease.
This innovative assay not only aims to enhance diagnostic accuracy but also reduce the time to obtain results, thereby expediting the onset of necessary treatment for patients suffering from these ailments. The assay's development is in alignment with the recent FDA listing of the preventive Class II 510(k) exempt approved MosaiQ instrument, showcasing an advanced solution tailored to modern clinical needs.
Streamlined Testing for Complex Conditions
One of the standout features of the MosaiQ AiPlex® VAS assay is its efficiency and simplicity. It requires only a minimal sample volume of 10 µl from the patient's serum, yet it performs comprehensive testing that amalgamates the results of all three sought-after autoantibody markers. The final report consolidates findings into a singular document, easing the burden on clinicians who require reliable and swift information for informed decision-making.
Based on the 2022 ACR/EULAR Classification Criteria for ANCA-associated vasculitides, and strategic guidance from the 2021 KDIGO Clinical Practice Guideline for glomerular disease management, this assay positions itself at the forefront of diagnostic innovation.
Statements from Leadership
Manuel O. Méndez, CEO of AliveDx, expressed enthusiasm regarding this submission, stating, "Submitting the 510(k) premarket notification to the FDA for our MosaiQ AiPlex VAS microarray is an important step in advancing innovative diagnostic solutions for clinicians and patients in the U.S. Our strategy reinforces our global aim of delivering solutions that offer heightened clinical and economic value, aspiring to enhance patient outcomes significantly."
This commitment is evidenced by AliveDx's recent accomplishments, which have seen the launch of over 90 IVD products globally within the past twelve months. These products include diverse assays tailored to provide in-depth diagnostic insights into conditions like Celiac disease and various connective tissue disorders. The breadth of these offerings is designed to empower clinicians and ultimately cater to clinical needs holistically.
The Future of Diagnostics with MosaiQ®
The MosaiQ® solution represents a state-of-the-art in-vitro diagnostic platform tailored for autoimmune and allergy diagnostics, among other uses. Its multiplex, fully automated planar microarray technology enables syndromic testing of multifaceted conditions, providing substantial throughput with continued random access. With an objective to meet the evolving expectations surrounding laboratory efficiency, the platform is engineered to deliver fast, reliable results while upholding a high standard for accuracy.
About AliveDx
With a legacy of over 30 years in the in-vitro diagnostics field, AliveDx is committed to redefining diagnostic insights and transforming patient care through continuous innovation. Its product portfolio, which includes brands like Alba, MosaiQ, and LumiQ, aims to simplify laboratory workflows while enhancing clinical decision-making. By prioritizing speed and accuracy, AliveDx seeks to create solutions that not only enhance healthcare outcomes but also foster a sustainable work environment for healthcare providers.
For more details on AliveDx and its pioneering IVD solutions, visit www.alivedx.com and follow them on LinkedIn and X.
Topics Health）
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