ENDRA’s TAEUS Device Matches MRI Accuracy for Liver Fat Measurement—Study Shows 90% Within 5% Error Margin
Feasibility Study Finds TAEUS Consistently Tracks Gold Standard MRI-PDFF
ENDRA Life Sciences’ latest feasibility study signals a potential turning point for how clinicians assess liver fat—a critical biomarker in metabolic dysfunction-associated steatotic liver disease (MASLD) and steatohepatitis (MASH). The company’s improved TAEUS Liver device, which uses the Thermoacoustic Fat Fraction (TAFF) method, demonstrated a high level of agreement with MRI-PDFF, the gold standard for non-invasive liver fat quantification.
For context, MRI-PDFF, while accurate, can cost upwards of $2,500 per scan and is often inaccessible for repeated patient monitoring. TAEUS, by comparison, offers point-of-care convenience and aims to match this level of performance at a much lower cost—a critical need in managing the more than 2 billion global cases of SLD, including over 100 million in the U.S.
Key Metrics: Over 90% of TAEUS Results Within 5% of MRI
The single-site study included 40 patients with BMI ranging from 21 to 47, representing the full spectrum from healthy livers to severe steatotic liver disease. Across this diverse cohort, the results showed:
| Key Metric | Result |
|---|---|
| Pearson Correlation Coefficient (r) | 0.89 |
| Deming Regression (slope, intercept) | 1, 0 (within 95% confidence vs. MRI) |
| Subjects within 5% Error vs. MRI-PDFF | 90% |
| Average Error | ~3% |
| BMI & Disease Stage Performance | Consistent accuracy across full spectrum |
In plain terms, TAEUS produced measurements that were closely matched to MRI-PDFF across all types of patients, including those with higher BMI—a segment where ultrasound-based fat quantification methods typically lose accuracy. For the vast majority, the TAEUS result differed from MRI by less than 5%, and on average, only about 3%.
Why This Matters: A Shift Toward Affordable, Frequent Liver Screening
Given evolving medical guidance and a surge in drug development for metabolic liver disease, reliable and repeatable liver fat measurement has become essential. MRI-PDFF’s cost and limited availability pose barriers, especially as many clinical trials now demand regular liver monitoring. TAEUS aims to fill this gap, providing practical, frequent assessments in clinics, and possibly broadening access to effective screening and longitudinal disease tracking.
Dr. Jonathan Rubin of the University of Michigan Medical School commented that the strong correlation with MRI-PDFF—even in higher BMI patients—suggests TAEUS could overcome longstanding challenges of conventional ultrasound approaches. This could transform care not only for millions of patients but also for pharmaceutical trials where accurate, repeatable liver monitoring is now a core requirement.
What’s Next: Pivotal Study and Broader Validation
ENDRA is already launching a follow-up study in London, Canada, to further validate these promising results across more centers and populations. The company also plans to align with the FDA regarding pivotal trial design, endpoints, and statistical methods as it seeks the green light for U.S. approval. With 50+ drug candidates in phase 2 or 3 trials requiring precise liver fat quantification, a scalable, accurate, and cost-effective solution could not be timelier.
Takeaway: If future results mirror this feasibility study, ENDRA’s TAEUS could play a crucial role in bringing MRI-level accuracy for liver fat assessment to more clinics, improving both disease management and trial outcomes. It’s a space to watch for patients, clinicians, and investors alike.
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