- Design
- Prospective multicentre diagnostic study, head-to-head with ultrasound, CT/MRI reference
- Population
- 2,293 evaluable adults with cirrhosis or chronic hepatitis B eligible for HCC screening (US)
- Primary outcome
- Early-stage HCC sensitivity (non-inferiority) and specificity
- Effect
- Early-stage sensitivity 66.7% vs 22.2% (difference 44.4 points); specificity 81.8% vs 98.6%
The ALTUS study prospectively compared a multi-target blood test (mt-HBT) head to head with surveillance ultrasound in 2,293 evaluable adults with cirrhosis or chronic hepatitis B eligible for hepatocellular carcinoma screening, using CT or MRI as the reference.
Among 37 cancers (27 early stage), the blood test detected 66.7% of early-stage cancers versus 22.2% for ultrasound, a 44-percentage-point absolute gain, and more than doubled any-stage detection. The trade-off was specificity: 81.8% for the blood test (just missing its 82% target) against 98.6% for ultrasound, meaning more false positives and downstream imaging.
This matters because ultrasound misses early tumours, especially in obesity and steatotic liver, and adherence is poor. A sensitive blood test could broaden surveillance, but the lower specificity means more benign scares and confirmatory scans. It is cross-sectional diagnostic performance, not evidence that the test lowers liver-cancer death, and it is not yet a guideline-endorsed substitute for imaging.
- The blood test detected 66.7% of early-stage liver cancers versus 22.2% for ultrasound.
- Any-stage detection was also more than doubled (73.0% vs 29.7%).
- Specificity was lower (81.8% vs 98.6%), so expect more false positives.
- It could help where ultrasound is limited, as in obesity or steatotic liver.
- This is diagnostic accuracy, not proof of reduced liver-cancer mortality.
Why it matters
It offers a route around ultrasound's poor early sensitivity and low uptake, the main weaknesses of current HCC surveillance.
Don't overread it
Cross-sectional diagnostic study; the lower specificity drives false positives, and it has not been shown to reduce liver-cancer mortality or endorsed to replace imaging.
The statistics, in plain English
A 44-point sensitivity gain is large, but specificity of 81.8% versus 98.6% means roughly one in five without cancer screens positive, generating confirmatory imaging; cross-sectional accuracy does not show the test saves lives.
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