We offer a turn-key medical imaging solution for clinical trials in non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD). Get quantitative, standardized insight into total patient health with our robust, quantitative biomarkers and AI-driven digital pathology services.
Liver Fat (MRI-PDFF)
Fibro-inflammation (cT1)
Liver Stiffness (MRE)
Digital Pathology
Imaging can be easily incorporated into phase I, II, and III NASH clinical trials to de-risk trial design and reduce costs through enhanced trial enrichment, early efficacy detection, and longitudinal monitoring.
Our cutting-edge, multiparametric MRI technology capabilities allow us to non-invasively characterise liver health by providing comprehensive measurements of liver fat, iron concentration, fibro-inflammation, and more.
cT1 and MRI-PDFF have both been shown to have high correlation with histological results of fibrosis, inflammation and steatosis.1,2,3,4,5Additionally, cT1 has been shown to reliably predict liver-related clinical outcomes.2
Multi-organ Characterisation:
Liver, kidneys, pancreas, spleen, heart, aorta, biliary tree, colon, body composition, and bone mineral density
Imaging Technologies include:
MRI, Computerised tomography (CT), positron emission tomography (PET), DXA, endoscopy, and digital pathology
Reduce the screen fail rate, improve the patient experience, and lower trial costs by pre-screening with our best-in-class imaging biomarkers before initial biopsy.
The histological features that contribute to steatohepatitis, including liver fat, fibrosis, and inflammation, can be characterised by measuring PDFF and cT1.1,2,3 Clinical studies have shown that cT1 helps effectively stratify NASH populations and enrich for patients with F2/3 fibrosis.6
Our biomarkers have excellent reproducibility and repeatability7 with diagnostic accuracy that is superior to others. This enables more reliable monitoring of disease progression as a response to treatment and allows smaller trials to be run with more confidence.
|
Biomarker |
Regulatory clearance |
Biomarker qualification |
Type |
Diagnostic accuracy (95% CI) |
|
PRO-C3 |
None |
LOI accepted into BQP May 2020 |
Blood
|
NAFLD vs NAFLD & F≥3 0.81 (0.74–0.87)8 |
|
NIS-4 |
None |
LOI accepted into BQP Feb 2020 |
Blood |
NAFLD vs NASH with Fibrosis 0.82 (0.78 – 0.85)9 |
|
ELF |
CE marked |
LOI accepted into BQP Feb 2020 |
Blood |
NAFLD/ Healthy vs NAFLD with activity 0.77 (0.67 -0.88)10 |
|
OWL |
CE marked |
LOI accepted into BQP Feb 2020 |
Blood |
NASH vs NAFLD 0.88 (0.85-0.91)11 |
|
FibroTest |
FDA and CE approvals not required |
No |
Blood |
Not reported |
|
cT1 |
FDA cleared and CE marked |
FDA BQP Full QP submitted Oct 2019 |
Imaging |
NAFLD/ Healthy vs NAFLD with activity 0.89 (0.83 – 0.95)10 |
|
PDFF |
FDA cleared and CE marked |
FDA BQP Full QP submitted Oct 2019 |
Imaging |
NAFLD/ Healthy vs NAFLD with activity 0.72 (0.59 – 0.84)12 |
|
MRE |
FDA cleared and CE marked |
No |
Imaging |
NAFLD vs NASH 0.70 (0.57 – 0.82)13 |
|
LSM-Fibroscan |
FDA cleared and CE marked |
LOI accepted into BQP May 2020 |
Imaging |
NAFLD/ Healthy vs NAFLD with activity 0.85 (0.76–0.93)10 |
Our proprietary technology corrects for iron content, field strength, and manufacturer differences to deliver a “corrected T1”. This allows more robust metrics to be collected to support multi-site trials.
Our standardised approach to biopsy processing and staining combined with our AI-driven, objective scoring systems decrease slide heterogeneity and reduce inter-/intra-reader variability.
Ballon cell count Balloon cell size and density
Peri-cellular fibrosis
Bridging fibrosis
MRE is another useful tool to provide supplementary assessment of fibrosis stage by liver stiffness. Our proven MR-imaging expertise enables us to provide the highest quality MRE metrics with superior accuracy and reproducibility.
Mean Liver Stiffness: 1.69 kPa
Mean Liver Stiffness: 5.4 kPa
We receive raw images acquired by our trained imaging centers and analyse them using proprietary artificial intelligence and machine learning algorithms.
All images are checked for quality, and every report undergoes a review process prior to return. Our Perspectum Portal performs a single platform for access to data and results.
Learn moreReferences
