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

ASX:RHT

HepaFat-Scan® Product Specifications

Sensitivity and Specificity

The HepaFatScan analysis has high sensitivity and specificity for predicting steatosis grade from liver biopsy.

Steatosis Grades Grade ≥ 1 Grade ≥ 2 Grade = 3
Sensitivity (95% conf interval) 0.97 (0.84-0.99) 0.86 (0.66-0.97) 0.92 (0.66-0.99)
Specificity (95% conf interval) 0.88 (0.64-0.99) 0.89 (0.71-0.98) 0.86 (0.70-0.95)

Vos, et al. (2020) GastroHep, 2: 171

Technical Specifications

Technology

3 point Dixon with a correction for iron contribution

HepaFat-Scan calibration and validation

Calibrated using 59 liver biopsies and validated using another 50 liver biopsies. Also validated in Children using 50 liver biopsies.

Evaluation

Volumetric liver fat fraction (VLFF)

Longitudinal monitoring capability

Yes

Patient age groups

All excluding neonates

Results generated

Within 24 hours (1 working day)

Data acquisition time

2 minutes

Breathhold requirements

Yes

Contrast agents

None

Slices

3

Data transfer and report delivery system

Via HIPPA & GDPR compliant secure portal system

Scanner compatibility

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

Software requirements

None

Hardware requirements

None specific as long as the required imaging protocol can be achieved

MRI scanner validation

scanner svgWith saline bag

Quality assured certification

ISO 13485:2016