Achyut Saroj, Founder, Consultant, and Author at AwareOnc, KOL Engagement and Medical Affairs Liaison at Tatva Health, shared a post on LinkedIn:
“HCC surveillance: Is there a performance gap in the GALAD score we need to address?
A recent Phase 3 validation study (Marsh et al., 2025) has provided a critical reality check for this biomarker algorithm. While GALAD represents a step forward from using α-fetoprotein (AFP) alone, several significant limitations challenge its role as a standalone surveillance strategy.
– The Prospective Reality: Retrospective studies often showed AUROCs >0.90, but prospective real-world performance in a large cohort of over 1,500 patients dropped to 0.78.
– Etiology Impact: There is a major sensitivity drop in non-viral liver diseases (49%) compared to viral etiologies (74%). This is particularly concerning, as MASLD is becoming the dominant cause of HCC.
– Demographic Bias: GALAD appears to be less reliable in women, potentially due to sex-dependent biomarker kinetics and the algorithm’s fixed weighting for gender.
– Sensitivity Limits: Even with GALAD, nearly 4 out of 10 HCC cases were missed within 12 months of diagnosis, with a prospective sensitivity of only 62%.
The strategic takeaway?
GALAD is currently best positioned as an adjunctive enrichment tool to refine risk assessment, rather than as a standalone replacement for established imaging-based surveillance.”
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