We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

Download Mobile App




Novel Multiplex Assay Supports Diagnosis of Autoimmune Vasculitis

By LabMedica International staff writers
Posted on 05 Sep 2025

Autoimmune vasculitis and related conditions are difficult to diagnose quickly and accurately, often requiring multiple tests to confirm the presence of specific autoantibodies. More...

Traditional methods can be time-consuming, causing delays in initiating treatment and increasing patient anxiety. Now, a new multiplex assay can simultaneously detect multiple markers, offering faster, more comprehensive diagnostic insights for autoimmune vasculitis.

AliveDx’s (Vaud, Switzerland) MosaiQ AiPlex Vasculitis (VAS) assay is designed to detect three key autoantibody markers—MPO, PR3, and GBM—from just 10 µl of patient serum. The assay is intended to be used on the MosaiQ instrument, which recently received its own FDA Class II 510(k) exempt approval. The multiplex assay provides a single report covering all markers, streamlining workflows while aligning with international diagnostic guidelines.

AliveDx has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its MosaiQ AiPlex Vasculitis (VAS) assay, building on its earlier rollout in CE-marked regions, where it has already been in clinical use since July 2025. The system has demonstrated the ability to deliver comprehensive results that cover all three markers cited in the 2022 ACR/EULAR Classification Criteria for ANCA-associated vasculitides and the 2021 KDIGO Clinical Practice Guideline for glomerular diseases.

AliveDx has launched over 90 IVD products globally in the past year, adding assays for autoimmune diseases like celiac disease and connective tissue disorders. The MosaiQ AiPlex VAS assay adds to this growing menu, offering clinicians greater efficiency and faster results in diagnosing complex conditions. With FDA review underway, the company plans to expand the MosaiQ portfolio in the U.S., further supporting clinicians with comprehensive autoimmune diagnostic solutions.

“Submitting the 510(k) premarket notification to the FDA for our MosaiQ AiPlex VAS microarray is an important step in advancing innovative diagnostic solutions for clinicians and patients in the U.S,” said Manuel O. Méndez, CEO of AliveDx. “Globally, AliveDx and our partners are advancing our goal to deliver solutions that provide greater clinical and economic value, ultimately aiming to improve patient outcomes.”

Related Links:
AliveDx


Gold Member
Immunochromatographic Assay
CRYPTO Cassette
Portable Electronic Pipette
Mini 96
Clinical Chemistry System
P780
6 Part Hematology Analyzer with RET + IPF
Mispa HX 88
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The novel approach could improve early cancer detection (Photo courtesy of AdobeStock)

Simple Blood Test Offers Non-Invasive Alternative for Early Colon Cancer Detection

Colorectal cancer remains one of the leading causes of cancer-related deaths, and early detection is critical for improving patient outcomes. Current methods, such as colonoscopy, are effective but invasive... Read more

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Technology

view channel
Image: The SWITCH hybrid pipette is designed to simplify and accelerate pipetting tasks (Photo courtesy of INTEGRA)

Hybrid Pipette Combines Manual Control with Fast Electronic Aliquoting

Manual pipettes offer the control needed for delicate tasks such as mixing or supernatant removal, but typically fall short in repetitive workflows like aliquoting. Electronic pipettes solve this problem... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.