21 Oct ACG 2022 Annual Scientific Meeting, Charlotte, North Carolina

ASX:RHT

FerriScan® Product Specifications

Sensitivity and Specificity

The FerriScan analysis has the highest sensitivity and specificity for predicting LIC measured from biopsy over the entire LIC range encountered in clinical practice.

LIC Threshold1 Clinical Relevance2 Sensitivity %3 Specificity %3
1.8 Upper 95% of normal 94%
(86-97)
100%
(88-100)
3.2 Suggested lower limit of optimal range for LICs for chelation therapy in transfusional iron loading 94%
(85-98)
100%
(91-100)
7.0 Suggested upper limit of optimal range for LICs for transfusional loading and threshold for increased risk of iron-induced complications 89%
(79-95)
96%
(86-99)
15 Threshold for greatly increased risk for cardiac disease and early death in patients with transfusional iron overload 85%
(70-94)
92%
(83-96)

1 LIC Threshold measured in (mg Fe/g dw).
2 Clinical Relevance taken from Olivieri and Brittenham, Blood 1997; 89:739-61.
3 *St. Pierre T.G., Clark P.R., Chua-anusorn W., Fleming A.J., Jeffrey G.P., Olynyk J.K., Pootrakul P., Robins E., Lindeman R. (2005) Noninvasive measurement and imaging of liver iron concentrations using proton magnetic resonance. Blood 105: 855-861.

Technical Specifications

Technology

SDPA (Spin Density Projection Assisted) R2-MRI.

FerriScan calibration

Calibrated against LIC from 105 biopsies using 5 different MRI scanners. The calibration has been independently validated on a further 233 LIC measurements from biopsy on another 5 different MRI scanners.

Confounding factors

None from inflammation, fibrosis, fat, scanner make/model and hardware setup

Evaluation

Liver Iron Concentration (LIC)

Longitudinal monitoring capability

Yes

Patient age groups

All including neonates

Results generated

Within 48 hours (working days)

Data acquisition time

10 minutes

Breathhold requirements

None

Contrast agents

None

Slices

11

Data transfer and report delivery system

Via HIPPA & GDPR compliant secure portal system

Scanner compatibility

Compatible on 1.5T and 3T machines, including ,, General Electrics and others.

Software requirements

None

Hardware requirements

Saline bag (imaged alongside every patient) 

MRI scanner validation

feriscan With FerriScan  Phantom Pack

Quality assured certification

ISO 13485:2016