#Switzerland #AliveDx #MosaiQ #Eysins #AiPlex CTDplus

Introduction

AliveDx has recently expanded its diagnostic product line with the introduction of the MosaiQ AiPlex® CTDplus multiplex test, which has received the IVDR-CE mark. This innovative test is designed to assist clinicians and laboratory staff in diagnosing systemic autoimmune rheumatic diseases (SARDs) effectively, while also streamlining laboratory workflow.

Addressing a Global Challenge

Systemic autoimmune rheumatic diseases, such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and scleroderma, represent a significant global health challenge. These diseases affect millions and are characterized by the production of autoantibodies, making diagnosis particularly complex due to overlapping clinical symptoms and high rates of co-occurrence among various connective tissue diseases. Often, this complexity leads to delays in diagnosis from the onset of symptoms.

To tackle this issue, detecting various autoantibodies in conjunction with clinical findings and other laboratory results is crucial for clinicians. The multiplex test offers a comprehensive profile of autoantibodies, reducing the time taken for diagnosis significantly.

Features of the MosaiQ AiPlex CTDplus Test

The MosaiQ AiPlex CTDplus test provides a syndromic approach and precise serological assessment of rheumatoid arthritis and connective tissue diseases for healthcare providers. It employs a unique combination of autoantibody tests that deliver a sensitive and specific diagnostic solution, allowing clinicians to gain actionable insights for enhancing patient care. Remarkably, it can generate results using only 10 µl of patient sample in a single step.

This innovative multiplex assay comprises 15 markers, including many autoantibodies recommended by prominent clinical guidelines (ACR/EULAR). The test allows for the simultaneous detection of autoantibodies against DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P, SS-A 60 (Ro60), SS-B (La), TRIM21 (Ro52), Jo-1, CENP-B, Scl-70, and RNA Polymerase III.

Commitment to Improving Patient Care

Manuel O. Méndez, CEO of AliveDx, expressed enthusiasm about receiving the fifth IVDR-CE mark in just 18 months, emphasizing the company's dedication to enhancing patient care. He stated, "Accurate and early diagnosis is essential for managing complex autoimmune diseases, and our MosaiQ AiPlex CTDplus test supports laboratory personnel and clinicians in achieving this goal. This milestone reflects our team's commitment to advancing diagnostic technologies and addressing the critical needs of patients with autoimmune diseases like RA and connective tissue diseases."

Looking Ahead

Looking to the future, AliveDx plans to expand its offerings with a new multiplex solution for vasculitis and antiphospholipid antibodies. This will further improve the diagnostic capabilities for systemic autoimmune diseases, reinforcing the company's purpose of transforming diagnostics.

The MosaiQ System: A Comprehensive Solution

The MosaiQ testing system is a cutting-edge in vitro diagnostic (IVD) solution for autoimmune diseases, allergies, and other conditions. This fully automated multiplex flat-panel biochip platform enables syndromic testing for complex conditions. The user-friendly platform features high throughput with continuous random access, providing quick and precise results that cater to the evolving expectations for laboratory efficiency. The system is capable of detecting and identifying up to 1,275 disease markers per hour for the MosaiQ AiPlex CTDplus solution, with internal calibration and quality control integrated into the biochip, simplifying laboratory workflows.

All multiplex biochip reagents and storage units are RFID-tagged to save time and minimize manual errors. For additional information regarding AliveDx and its diagnostic solutions, visit Alivedx.com.

About AliveDx

AliveDx is committed to enhancing diagnostic knowledge, transforming patient care, and innovating for life. With over 30 years of experience in in vitro diagnostics, AliveDx is dedicated to shaping the future of global diagnostics in the fields of autoimmunity, allergy, and beyond. Its innovative solutions enable laboratories and clinicians to accelerate diagnostics and improve patient lives, all while fostering a positive and sustainable work environment for healthcare providers. The company’s portfolio includes brands such as Alba, MosaiQ, and LumiQ, offering value through streamlined laboratory workflows and timely, precise results that enhance clinical decision-making. AliveDx is committed to innovating for life.