Alivedx, the global In-vitro-Diagnostics company that has set itself the goal of revolutionizing patient care today announces that the US Food and Drug Administration (FDA) an application for market registration (510 (K)) for the Mosaiq Aiplex® Vasculitis (VAS)-Assay* has submitted.
The Mosaiq Aiplex® VAS-Multiplex Assay was developed to improve the examination of anti-MPO, anti-pr-3 and anti-GBM for ANCA-associated vasculitis (anti-neutrophilic cytoplasmic antibodies) and anti-GBM (Goodpasture syndrome) and to shorten the time until the results are diagnosis To support autoimmunvasculitis. The Assay is intended for use with the approved Mosaiq device recently listed by the FDA and excluded from class II 510 (K). The corresponding assay has been available in stores in countries with IVDR CE marking since July 2025 after the IVDR certification has been received.
Mosaiq Aiplex® VAS-Multiplex-Assay*: fast, simple, comprehensive
The Mosaiq Aiplex VAS-Multiplex-Assay is used for the simultaneous detection of three autoantibodies markers-MPO, PR3 and GBM-using only 10 µl patient serum. The Assay is carried out on the MosaiQ device and provides a single result report that covers all three markers.
These markers are described in the ACR/EULAR classification criteria for ANCA-associated vasculitis from 2022 (1)-(3) and in the Kdigo guidelines for clinical practice for the treatment of glomerular diseases of 2021 (4).
“The submission of the 510 (K) prerequisite at the FDA for our Mosaiq Aiplex VAS-MICROARARAR is an important step towards promoting innovative diagnostic solutions for doctors and patients in the USA,” said Manuel O. Méndez, CEO from Alivedx. “Worldwide, Alivedx and our partners are driving our goal of offering solutions that offer a greater clinical and economic value, with the ultimate goal of improving treatment results for patients.”
The prerequisite is followed by Alivedx’s recent successes, which has launched over 90 IVD products worldwide in the past 12 months, including assays, which provide comprehensive diagnostic findings for celiac disease, connective tissue and vasculitis. This extensive offer will provide important insights that enable doctors to better support the needs of their patients.
*This product is currently not available in the United States and is not approved or approved by the US Food and Drug Administration (FDA) for clinical use.
Information on the Mosaiq solution®
The MosaiQ solution is a state-of-the-art IVD solution for autoimmune diseases, allergies and beyond. The multiplexes, fully automatic planar microarray platform enables syndomic tests for complex diseases. This intuitive platform offers a high throughput with continuous direct access and provides quick and precise results that meet the changing requirements and expectations of laboratory efficiency.
Information on Alivedx
Alivedx has set itself the task of gaining diagnostic knowledge, improving patient care and creating innovations for life. With more than 30 years of experience in in-vitro diagnostics, we devote ourselves to the design of the future of global diagnostics in the field of autoimmune diseases, allergies and beyond. Our groundbreaking solutions enable laboratories and clinicians to accelerate diagnoses, improve the life of the patient and at the same time create a positive and sustainable work environment for health service providers. Our portfolio includes the Alba, Mosaiq and Lumiq brands. These solutions aim to generate both economic and clinical benefits by simplifying laboratory processes and providing fast, precise results that improve clinical decision -making. At AlivedX we develop innovations for life.
For more information about AlivedX and his IVD solutions, please visit www.alivedx.com and follow us LinkedIn and X.
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- Robson JC et al. 2022 ACR/EULAR GPA Classification Criteria.Ann Rheum Dis. 2022;81(3):315-320.
- Suppiah R et al. 2022 ACR/EULAR MPA Classification Criteria.Ann Rheum Dis. 2022;81(3):321-326.
- Grayson PC et al. 2022 ACR/EULAR EGPA Classification Criteria.Ann Rheum Dis. 2022;81(3):309-314.
- Kdigo 2021 Clinical Practice guideline for the treatment of glomerular diseases. Kidney int. 2021; 100 (4S): S1-S276.
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