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Page 8 of 16 Iruzubieta et al. Metab Target Organ Damage. 2025;5:10 https://dx.doi.org/10.20517/mtod.2024.143

evidence highlighting the risks and limitations of liver biopsy. Non-invasive techniques, such as transient
elastography and serum biomarkers for liver fibrosis, have greatly improved the early detection and
[49]
monitoring of MASLD . These methods provide a safe and effective assessment of liver fibrosis without
the risks inherent to biopsy. While liver biopsy continues to offer detailed insights into steatosis,
inflammation, and fibrosis, the adoption of non-invasive techniques has lowered the barriers to diagnosing
and monitoring MASLD, enhancing clinical workflow and patient care. However, histological assessment
remains relevant in certain contexts, particularly for evaluating disease activity. The NAFLD Activity Score
(NAS), originally developed for NAFLD, remains a widely used tool for grading steatosis, inflammation,
and ballooning degeneration. Given that the histopathological features of MASLD largely overlap with those
of NAFLD, the NAS score continues to be applicable.

The removal of liver biopsy as a diagnostic requirement for MASLD also has significant implications for
primary care. It enables general practitioners to take a more active role in diagnosing and managing these
[50]
patients, enabling evaluations and follow-ups without the immediate need for specialist referral . This shift
enhances diagnostic accessibility but underscores the importance of proper training for primary care
physicians in using and interpreting non-invasive diagnostic tools to ensure optimal patient management.
The adoption of non-invasive tests not only reduces the risks associated with liver biopsy but also decreases
the costs related to invasive procedures. However, it is crucial to ensure the standardized implementation of
[51]
these methods in clinical practice . Clear guidelines and protocols must be established to guarantee
consistent evaluation and minimize the risk of diagnostic errors.

Despite the advances in non-invasive methods, there remains a subset of patients for whom liver biopsy is
still necessary. This is particularly true in cases where non-invasive test results are inconclusive or when
dual or concomitant liver pathologies are suspected. In such scenarios, biopsy remains an indispensable tool
for achieving a definitive diagnosis and guiding appropriate treatment.

THE IMPACT OF MASLD ON RESEARCH
The global adoption of the term MASLD has significant implications for research and treatment
development. While this transition may initially raise concerns about the validity of previous studies on
NAFLD and NASH, existing evidence indicates a high concordance between these classifications and
MASLD, reducing the risk of invalidating earlier findings [52-54] . Nevertheless, further studies are needed to
validate biomarkers specifically within the MASLD framework, presenting opportunities to refine
diagnostic and predictive tools.

The shift from NAFLD/NASH to MASLD/MASH introduces challenges in extrapolating data from prior
research to the new nomenclature. Although MASLD’s diagnostic criteria are simpler and more clinically
applicable, patient selection for clinical trials may face complications, potentially affecting the
generalizability of previous results. However, the updated criteria are expected to enhance patient
stratification and foster greater homogeneity in future studies, ultimately benefiting clinical trials and drug
development.

The unified MASLD criteria represent a major advancement for global research. By using simpler and more
inclusive clinical parameters, MASLD facilitates data comparison across studies and populations,
overcoming the limitations of the more complex NAFLD and NASH definitions. This standardization
enhances collaboration between research centers, promotes multicenter clinical trials, and accelerates the
development of new treatments [55,56] . Moreover, MASLD’s simplicity enables large-scale data collection,
leading to more robust and reliable results. MASLD thus represents a critical step forward in aligning