AliveDx Launches Innovative Multiplex Assay to Enhance Autoimmune Diagnostics

AliveDx Launches Innovative Multiplex Assay to Enhance Autoimmune Diagnostics



AliveDx has made a significant advancement in autoimmune diagnostics with the introduction of its MosaiQ AiPlex® CTDplus multiplex assay, recently granted the IVDR-CE mark. This new assay is designed to support the diagnosis of Systemic Autoimmune Rheumatic Diseases (SARDs) by employing a syndromic approach that simplifies laboratory workflows while providing fast and reliable results.

Understanding Systemic Autoimmune Diseases



Systemic autoimmune rheumatic diseases, including Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus, and Systemic Sclerosis among others, impact millions around the globe. These conditions are characterized by the body's immune system mistakenly attacking its own tissues, leading to symptoms that can often overlap, complicating the diagnosis process. The presence of various autoantibodies plays a crucial role in identifying these diseases, yet the intricate symptoms often lead to delayed diagnoses.

Traditionally, diagnosing these disorders required multiple tests, which could prolong the time to conclude. AliveDx's multiplex assay addresses this challenge by delivering a comprehensive autoantibody profile in a single test. This innovation significantly reduces the diagnosis time, allowing healthcare providers to make informed clinical decisions swiftly.

Features of the MosaiQ AiPlex CTDplus Assay



The MosaiQ AiPlex CTDplus assay is distinguished by its rapid, single-step execution, needing just 10 μl of patient samples to generate results. The assay panel comprises 15 markers, including all major autoantibodies recommended by leading clinical guidelines. These markers include DFS70/LEDGF, CCP, and various others crucial for accurate diagnosis.

Manuel O. Méndez, CEO of AliveDx, expressed enthusiasm over this milestone, noting, "This illustrates our commitment to enhancing patient care through early and precise diagnosis for complex autoimmune diseases. Our latest assay further empowers clinicians and laboratorians worldwide, allowing them to address the significant healthcare needs of patients with autoimmune disorders."

Advancements in Laboratory Workflow



The MosaiQ® system stands out in the field of diagnostics due to its advanced workflow capabilities. It integrates a fully automated planar microarray platform that streamlines testing for complex conditions. The system not only provides high throughput but also facilitates rapid disease marker detection—up to 1,275 markers in an hour—enabling laboratories to operate efficiently.

The automation reduces manual errors and supports internal calibration, ensuring high-quality control measures are upheld throughout the testing process. The use of RFID tags on reagents and microarrays further minimizes potential errors, offering a scalable and robust solution for healthcare providers.

Future Developments



Looking ahead, AliveDx plans to enhance its offerings by developing multiplex solutions for vasculitis and antiphospholipid syndrome, addressing additional systemic autoimmune conditions that require clinical attention.

At AliveDx, the mission focuses on transforming patient diagnostics and care through innovative solutions that are both efficient and effective. With over three decades of expertise in in-vitro diagnostics, the company aims to pave the way for future advancements in the field, ultimately improving the quality of care for patients with autoimmune diseases.

For more information and insights on AliveDx and their groundbreaking diagnostic solutions, visit Alivedx.com.

Topics Health)

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