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LITMUS Changes the Biopsy Calculus: What the Nature Medicine Data Means for Your ...
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Fusion42 · 5 August 2026 · Fusion42 review
The LITMUS cohort study validates non-invasive liver fibrosis tests like VCTE against biopsy-level clinical outcomes at scale, supporting the FDA and EMA's regulatory progression towards approving these alternatives as surrogate endpoints in MASLD trials. This shift promises to disrupt traditional biopsy-dependent protocols by enabling faster, less invasive patient screening and broader site participation.
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Your MASLD trial can now ditch biopsy for quicker enrolment and more representative patients. The FDA’s new acceptance of VCTE as a surrogate endpoint opens a door to redesigning liver fibrosis trials that were stuck in the past.
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1 source · 5 Aug 2026
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