ENDRA Life Sciences has reported results from a clinical study showing the Taeus Liver device’s high measurement consistency in metabolic dysfunction-associated steatotic liver disease (MASLD).
The study focused on the intra-user reproducibility and repeatability of the Taeus Liver device, factors critical for consistent long-term MASLD monitoring.
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It involved 14 participants, with multiple operators conducting several measurements on each of them.
Researchers collected 56 unique data points to evaluate the gage repeatability and reproducibility (R&R) associated with the device. This approach supports regulatory validation by quantifying measurement variability originating from the system itself, rather than genuine differences between patients.
Such validation is fundamental for clinical decision-making concerning both diagnostic and treatment thresholds.
The Taeus Liver device achieved an intraclass correlation coefficient (ICC) of 0.89 and a standard error of measurement (SEM) of 3.3%.
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By GlobalDataENDRA Life Sciences CEO Alexander Tokman said: “While MRI-PDFF remains the gold standard for liver fat quantification, its high cost and limited availability create significant barriers for the more than two billion people afflicted by MASLD.
“These new performance data showing a 3.3% SEM and a 0.89 ICC strongly support our belief that Taeus can deliver consistent results similar to an MRI, but at the point of patient care and at a much lower cost. This addresses a critical need for clinicians and pharmaceutical companies that require a diagnostic tool to monitor treatment frequently and affordably.”
The results highlight a strong contrast to traditional ultrasound methods, which often suffer from high variability and subjective readings. The device could standardise liver fat assessment for routine clinical use as well as pharmaceutical industry trials.
In February 2024, ENDRA announced the installation of its first Taeus liver system at London’s King’s College Hospital NHS Foundation Trust in the UK.
