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
LGC Clinical Diagnostics

Randox Laboratories

Provides global diagnostic solutions for hospital laboratories, forensic laboratories, research laboratories, pharmac... read more Featured Products: More products

Download Mobile App




Novel Assay Determines Medication Received by Hemophilic Patients

By LabMedica International staff writers
Posted on 02 Jun 2025

Dosing accuracy has long been a challenge in the treatment of hemophilia, especially when it comes to monitoring how much medication a patient has actually received. More...

Now, a breakthrough test designed to measure drug levels in hemophilia patients and support more precise dose adjustments.

ConcizuTrace ELISA (enzyme-linked immunosorbent assay), developed by Randox Laboratories (Crumlin, UK) in close partnership with Novo Nordisk (Bagsværd, Denmark), quantitatively measures concizumab-mtci levels in blood plasma. Specifically, it is intended for use in hemophilia A and B patients four weeks after they begin treatment, helping clinicians decide whether a dosage change is needed in line with the drug’s labeling.

Randox has received approval from the U.S. Food and Drug Administration (FDA) for its De Novo application for ConcizuTrace ELISA, making it the company’s first CDx to receive such an approval. The newly approved diagnostic is part of the broader Randox ConcizuTrace ELISA Service Solution — a comprehensive offering that includes a sample collection kit, the diagnostic test itself, and a web portal for managing patient data and test results. The platform is supported by robust logistical and technical infrastructure designed to streamline sample collection, analysis, and reporting.

With a global testing network now active in the US, Europe, and Japan, Randox ensures a 10-working day turnaround time for results. Partner labs have been selected based on stringent quality and technical standards to meet international testing needs. Over the course of the collaboration, testing laboratories have become active in US, Europe and Japan as the ConcizuTrace ELISA assay is already approved in both regions. This milestone marks a significant advancement in individualized care for hemophilia patients, offering clinicians a reliable way to monitor treatment efficacy.

Related Links:
Randox


New
Gold Member
Blood Gas Analyzer
Stat Profile pHOx
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Host Response Immunoassay Test
MeMed BV
New
Autoimmune Disease Diagnostic
Chorus ds-DNA-G
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

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more

Pathology

view channel
These images illustrate how precision oncology Organ Chips recapitulate individual patients’ responses to chemotherapy (Photo courtesy of Wyss Institute at Harvard University)

Cancer Chip Accurately Predicts Patient-Specific Chemotherapy Response

Esophageal adenocarcinoma (EAC), one of the two primary types of esophageal cancer, ranks as the sixth leading cause of cancer-related deaths worldwide and currently lacks effective targeted therapies.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.