Home·Know Your Companions™·Tests·ConcizuTrace ELISA
FDA-approved companion diagnostic

ConcizuTrace ELISA

Quantitative ELISA that measures concizumab-mtci levels in citrated plasma from hemophilia A and B patients to support dose adjustment of non-factor replacement prophylaxis.

IVD-developed CDxMethod: ELISASpecimen: PlasmaBiomarker: Concizumab-mtci plasma concentration
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
DEN240035
Supplements
Manufacturer
Randox Laboratories Ltd.
Approval date
May 22, 2025
Test specifications
Methodology
ELISA
Specimen
Plasma
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Concizumab-mtci plasma concentration
What this test is

ConcizuTrace ELISA is an FDA-authorized, manual enzyme-linked immunosorbent assay that quantitatively measures concizumab-mtci concentration in 3.2% citrated plasma from patients with hemophilia A or B after at least 4 weeks of therapy. Results are used to assess drug exposure and support dose adjustment decisions for non-factor replacement prophylaxis in line with the concizumab prescribing information.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Hemophilia A patients with or without factor VIII inhibitors and Hemophilia B patients with or without IX inhibitorsConcizumabTissue factor pathway inhibitor antagonistALHEMO

IVD Manufacturer

Randox Laboratories Ltd.

Randox is a global leader in healthcare diagnostics, committed to improving health worldwide through innovative diagnostic solutions. With a focus on quality and precision, Randox Laboratories continues to push the boundaries of diagnostic technology, delivering cutting-edge products that enhance laboratory efficiency and patient care.

Order this test

If your organization is connected to Casandra, you can place an electronic order forConcizuTrace ELISA directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

© 2025 Casandra.ai