MosaiQ AiPlex® Vasculitis Test Now Available for Clinical Use in Europe
AliveDx, a global leader in in vitro diagnostics, has announced the clinical availability of its MosaiQ AiPlex® Vasculitis test in the European Union and other countries that accept CE marking. This groundbreaking test is a significant advancement in the diagnosis and management of autoimmune vasculitis, particularly conditions related to anti-neutrophil cytoplasmic antibodies (ANCA) and anti-glomerular basement membrane (anti-GBM) disease.
The MosaiQ AiPlex VAS test is designed not only to expedite the result turnaround time but also to simplify laboratory workflows. Autoimmune vasculitis encompasses several complex syndromes, including Granulomatosis with Polyangiitis (GPA, previously known as Wegener's Granulomatosis), Microscopic Polyangiitis (MPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly Churg-Strauss syndrome). Unmanaged anti-GBM disease can lead to life-threatening complications, making timely and accurate diagnosis critical.
Given the challenges in diagnosing vasculitis—characterized by inflammation of blood vessel walls—the MosaiQ AiPlex VAS test innovatively combines rapid testing with a multiplex approach. Utilizing only 10 μl of patient serum, it delivers results for three key autoantibodies—MPO, PR3, and GBM—in a single comprehensive report. This falls in line with the latest clinical guidelines for the management of ANCA-associated vasculitis from ACR/EULAR (2022) and KDIGO (2021).
Manuel O. Méndez, CEO of AliveDx, asserts that this momentous milestone aligns with their mission to enhance healthcare solutions across Europe, echoing their commitment to delivering exceptional safety, performance, and quality standards. "Using our MosaiQ technology, we provide fully automated multiplex test results rapidly, enhancing the potential for early diagnosis in autoimmune conditions while decreasing healthcare costs."
The intuitive platform integrates high-throughput automated multiplex testing capabilities, streamlining workflows and improving patient care delivery. Through the consolidation of multiple relevant markers into one test, it translates into actionable insights for clinicians, thereby reducing intervention time and optimizing the use of laboratory consumables. Every chip's calibration is embedded at the manufacturing point, effectively saving laboratory time. Each multiplex array and reagent is also equipped with RFID tags, automating processes to minimize manual errors and enhance efficiency.
AliveDx remains steadfast in its commitment to advancing diagnostic knowledge and transforming patient care. Boasting over three decades of experience in in vitro diagnostics, they aim to redefine the global diagnostic landscape, focusing on autoimmunity, allergies, and beyond. Their array of innovative solutions, including brands like Alba, MosaiQ, and LumiQ, are pivotal in accelerating diagnostics and vital to improving quality of life for patients while fostering sustainable work environments for healthcare providers.
About AliveDx: AliveDx is at the forefront of diagnostic innovation, dedicated to shaping the future of diagnostic solutions. Their advanced MosaiQ platform supports syndrome testing for complex pathologies, ensuring a high yield while meeting the ever-evolving laboratory efficiency expectations. For additional information about AliveDx and its pioneering solutions, visit www.alivedx.com or connect with them on LinkedIn and X.
Note: The MosaiQ AiPlex test is not presently available in the U.S. and has not received FDA approval for clinical use.
References:
1. Treppo E et al. Systemic vasculitis one year in review 2024. Clin Exp Rheumatol. 2024;42(4)771-781.
2. Robson JC et al. 2022 ACR/EULAR GPA Classification Criteria. Ann Rheum Dis. 2022;81(3)315–320.
3. Suppiah R et al. 2022 ACR/EULAR MPA Classification Criteria. Ann Rheum Dis. 2022;81(3)321-326.
4. Grayson PC et al. 2022 ACR/EULAR EGPA Classification Criteria. Ann Rheum Dis. 2022;81(3)309-314.
5. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S)S1-S276.
The MosaiQ AiPlex VAS test is designed not only to expedite the result turnaround time but also to simplify laboratory workflows. Autoimmune vasculitis encompasses several complex syndromes, including Granulomatosis with Polyangiitis (GPA, previously known as Wegener's Granulomatosis), Microscopic Polyangiitis (MPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA, formerly Churg-Strauss syndrome). Unmanaged anti-GBM disease can lead to life-threatening complications, making timely and accurate diagnosis critical.
Given the challenges in diagnosing vasculitis—characterized by inflammation of blood vessel walls—the MosaiQ AiPlex VAS test innovatively combines rapid testing with a multiplex approach. Utilizing only 10 μl of patient serum, it delivers results for three key autoantibodies—MPO, PR3, and GBM—in a single comprehensive report. This falls in line with the latest clinical guidelines for the management of ANCA-associated vasculitis from ACR/EULAR (2022) and KDIGO (2021).
Manuel O. Méndez, CEO of AliveDx, asserts that this momentous milestone aligns with their mission to enhance healthcare solutions across Europe, echoing their commitment to delivering exceptional safety, performance, and quality standards. "Using our MosaiQ technology, we provide fully automated multiplex test results rapidly, enhancing the potential for early diagnosis in autoimmune conditions while decreasing healthcare costs."
The intuitive platform integrates high-throughput automated multiplex testing capabilities, streamlining workflows and improving patient care delivery. Through the consolidation of multiple relevant markers into one test, it translates into actionable insights for clinicians, thereby reducing intervention time and optimizing the use of laboratory consumables. Every chip's calibration is embedded at the manufacturing point, effectively saving laboratory time. Each multiplex array and reagent is also equipped with RFID tags, automating processes to minimize manual errors and enhance efficiency.
AliveDx remains steadfast in its commitment to advancing diagnostic knowledge and transforming patient care. Boasting over three decades of experience in in vitro diagnostics, they aim to redefine the global diagnostic landscape, focusing on autoimmunity, allergies, and beyond. Their array of innovative solutions, including brands like Alba, MosaiQ, and LumiQ, are pivotal in accelerating diagnostics and vital to improving quality of life for patients while fostering sustainable work environments for healthcare providers.
About AliveDx: AliveDx is at the forefront of diagnostic innovation, dedicated to shaping the future of diagnostic solutions. Their advanced MosaiQ platform supports syndrome testing for complex pathologies, ensuring a high yield while meeting the ever-evolving laboratory efficiency expectations. For additional information about AliveDx and its pioneering solutions, visit www.alivedx.com or connect with them on LinkedIn and X.
Note: The MosaiQ AiPlex test is not presently available in the U.S. and has not received FDA approval for clinical use.
References:
1. Treppo E et al. Systemic vasculitis one year in review 2024. Clin Exp Rheumatol. 2024;42(4)771-781.
2. Robson JC et al. 2022 ACR/EULAR GPA Classification Criteria. Ann Rheum Dis. 2022;81(3)315–320.
3. Suppiah R et al. 2022 ACR/EULAR MPA Classification Criteria. Ann Rheum Dis. 2022;81(3)321-326.
4. Grayson PC et al. 2022 ACR/EULAR EGPA Classification Criteria. Ann Rheum Dis. 2022;81(3)309-314.
5. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S)S1-S276.
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