Expanding Diagnostics for Vasculitis
AliveDx, a pioneering global in vitro diagnostics company, has achieved a significant milestone in medical technology with the introduction of its MosaiQ AiPlex® Vasculitis (VAS) assay. This innovative assay is now officially CE-marked and ready for clinical use in the European Union, enhancing healthcare protocols for diagnosing autoimmune vasculitis.
The Necessity of Timely Diagnosis
Vasculitis encompasses a group of diseases characterized by inflammation of blood vessel walls, often leading to severe organ damage. Conditions associated with ANCA (anti-neutrophil cytoplasmic antibodies) require prompt diagnosis and treatment, as delays can result in life-threatening consequences. The MosaiQ AiPlex VAS assay has been developed to reduce turnaround times for test results, thus supporting timely diagnosis and treatment.
The assay includes testing for three important autoantibodies: MPO (myeloperoxidase), PR3 (proteinase 3), and GBM (glomerular basement membrane), all consolidated into a single report that simplifies serological evaluations. This approach aligns with best practices suggested by clinical guidelines, including the recent ACR/EULAR recommendations.
Features of the MosaiQ AiPlex Assay
What sets the MosaiQ AiPlex VAS assay apart is its ability to deliver multiplexed results from just 10 μl of patient serum. The incorporation of advanced automation technology means that healthcare providers can receive quick and comprehensive insights into their patients’ health, improving decision-making processes significantly.
AliveDx's commitment to enhancing patient care is evident in its efforts to streamline laboratory workflows. The internal calibration of microarrays is integrated at the manufacturing stage, reducing time spent on processing and translating into quicker diagnoses. Furthermore, the assay's reagents are equipped with RFID tags, reinforcing automation and minimizing human error in laboratory settings.
CEO Manuel O. Méndez emphasizes the importance of this advancement: “Our MosaiQ technology provides fast, multiplexed results that enhance diagnosis speeds, ultimately improving treatment outcomes while also reducing healthcare costs.”
A Broad Impact on Patient Care
This new assay is a vital tool for physicians managing patients with varying forms of vasculitis, including Granulomatosis with Polyangiitis, Microscopic Polyangiitis, and Eosinophilic Granulomatosis with Polyangiitis. Each of these conditions presents unique challenges in terms of detection and management, affirming the necessity of timely and accurate diagnostic methods.
The impact of efficient diagnostics extends beyond individual patients, potentially influencing overall healthcare systems by alleviating burdens on laboratories and reducing associated costs through quicker, more accurate diagnostics.
About AliveDx
With over three decades of expertise, AliveDx has committed itself to transforming patient care through innovative diagnostics solutions. Their portfolio includes top-tier products focusing on autoimmune diseases, allergies, and various complex conditions. The overarching goal of AliveDx is to create diagnostic insights that enhance patient management while fostering a positive and efficient working environment for healthcare providers.
To learn more about the MosaiQ AiPlex VAS assay and the many advancements in diagnostic technology by AliveDx, please visit
www.alivedx.com and follow them on LinkedIn and Twitter.
Note: This product is available for clinical use in areas with CE marking approval but is not available in the United States.
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.