FDA-approved companion diagnostic

FerriScan

MRI-based R2 analysis service that quantifies liver iron concentration to noninvasively assess iron overload and support management decisions in at-risk patients.

IVD-developed CDxMethod: ImagingBiomarker: Liver iron concentration (LIC)
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
DEN130012 / K124065
Supplements
Manufacturer
Resonance Health Analysis Services Pty Ltd
Approval date
January 23, 2013
Test specifications
Methodology
Imaging
Turnaround (typical)
Not specified
Report format
Comprehensive report PDF
Biomarker(s)
Liver iron concentration (LIC)
What this test is

FerriScan is an MRI-based R2 analysis service that converts liver MRI images into a quantitative liver iron concentration (LIC) value. Provided as a centralized post-processing solution, it offers accurate, reproducible LIC across the full clinical range, helping clinicians diagnose iron overload and guide monitoring and treatment decisions in patients with thalassemia and other iron-loading disorders.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Transfusion-Dependent ThalassemiaLiver iron concentration imagingbased on the proton transverse relaxation rate of MRI imagesEXJADE

IVD Manufacturer

Resonance Health Analysis Services Pty Ltd

Resonance Health Analysis Services Pty Ltd is an Australian healthcare company specialising in the development and delivery of non-invasive medical imaging software and services. Its MRI-based solutions, such as quantitative liver iron assessment, are used by clinicians to support diagnosis and management of disease and by pharmaceutical companies in clinical trials worldwide.

Order this test

If your organization is connected to Casandra, you can place an electronic order forFerriScan 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.

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