#Switzerland #AliveDx #MosaiQ #Eysins #Vasculitis

Introduction

AliveDx, an innovative player in the in vitro diagnostics industry, has made a significant stride in the realm of autoimmune disease detection with its latest innovation, the MosaiQ AiPlex® Vasculitis assay. Recently gaining IVDR-CE Mark approval, this multiplexed test is now accessible for clinical use throughout the European Union and other regions that recognize the CE marking.

The Significance of the MosaiQ AiPlex® Assay

The MosaiQ AiPlex VAS assay is designed to expedite the diagnosis process for autoimmune vasculitides, which encompasses three critical syndromes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). These conditions can lead to severe complications if not managed promptly. The assay also aids in identifying Anti-GBM disease, a condition that can have life-threatening consequences when untreated.

Challenges in Diagnosis

Vasculitides are characterized by inflammation of blood vessels, which can disrupt blood flow and lead to serious organ damage. They present a complex diagnostic challenge due to their varied symptoms and the size of affected vessels. For healthcare professionals, timely and accurate diagnosis is critical, and this new assay is intended to mitigate those challenges.

How the MosaiQ AiPlex VAS Assay Works

What sets the MosaiQ AiPlex VAS assay apart from traditional testing methods is its efficiency. Utilizing just 10μl of serum, this assay effectively evaluates three essential autoantibody markers - MPO, PR3, and GBM - and delivers comprehensive results in a single report. This streamlined approach aligns with established clinical guidelines, specifically the 2022 ACR/EULAR guidelines for managing ANCA-associated vasculitis.

Enhanced Workflow and Automation

As healthcare systems continually seek more efficient methods for processing diagnostic tests, the MosaiQ solution addresses this by integrating high-throughput capabilities with automated multiplexing functions. The result is a reduction in hands-on time and a considerable decrease in the use of consumables, all while maintaining the highest levels of accuracy.

CEO Remarks

Manuel O. Méndez, CEO of AliveDx, expressed his enthusiasm about the assay, stating, "Our MosaiQ technology provides multiplexed test results fully automated and at speed, significantly reducing diagnosis time for autoimmune disorders. Achieving IVDR-CE Mark approval is a monumental achievement for us, reaffirming our commitment to delivering superior healthcare solutions across Europe."

Key Features of the MosaiQ AiPlex VAS Assay

• - Fast Results: The automation in testing allows for quicker diagnoses, critical for conditions that require immediate action.
• - Comprehensive Report: Clinicians receive detailed information pertaining to the necessary autoantibody markers that aid in ensuring accurate diagnosis and treatment.
• - User-Friendly Design: The assay is crafted to integrate seamlessly into existing laboratory workflows, simplifying the overall testing process.

Conclusion

The introduction of the MosaiQ AiPlex® Vasculitis assay by AliveDx marks a significant advancement in the diagnostic landscape for autoimmune diseases. With its capability to provide rapid, accurate results and enhance clinical decision-making, it represents a leap forward in patient care. As healthcare professionals embrace this innovative tool, it stands to considerably improve patient outcomes in the management of vasculitides across Europe.

For further information on AliveDx and the MosaiQ solutions, visit www.alivedx.com.