Metabolic dysfunction-associated steatotic liver disease (MASLD) and its progressive form, metabolic dysfunction-associated steatohepatitis (MASH), are rapidly emerging as global health priorities. Affecting up to 30% of the adult population, MASLD is a complex, multifactorial condition that can progress to MASH, cirrhosis, liver cancer, or metALD --posing significant challenges for drug developers. Overcome these challenges with a comprehensive, biomarker-driven approach that supports early diagnosis, patient stratification, and therapeutic monitoring—while streamlining global operations and accelerating development timelines.
Proven experience in MASLD/MASH with collaborative support for biomarker strategy, assay selection and regulatory alignment
Global laboratory capabilities with integrated testing, including safety, specialty and anatomic pathology, with experience across more than 110 clinical trials from 2015-2025
Study-specific databases that integrate biomarker, safety and exploratory data for faster decision-making
Labcorp offers a robust and continuously expanding toolkit of biomarkers to support the detection, staging and monitoring of MASLD/MASH. Our capabilities include:
| Group | Biomarkers |
|---|---|
| Non-invasive diagnostic tools |
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| Advanced lipid and metabolic profiling | Labcorp NMR platform:
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| Proprietary & partnered assays |
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Enhance your drug development programs with Labcorp’s comprehensive solutions and insights across multiple therapeutic areas.
Let's discuss your program to determine how we can help accelerate your MASLD/MASH clinical trials.
MASLD/MASH doesn’t have just one cause. It’s linked to obesity, diabetes and high blood pressure and can progress differently from each patient depending on factors like health history, genetic background and lifestyle. New treatments working across many different systems in the body may have variable outcomes making it harder to assess the safety and effectiveness of new drug candidates.
Liver biopsy remains the gold standard for diagnosing and staging MASLD/MASH and monitoring the effects of treatments, but its invasiveness limits its use in large-scale trials. Noninvasive biomarkers and imaging tools are improving in the sensitivity and specificity that regulatory bodies require. Bridging this diagnostic gap has great potential to speed up trial recruitment and make enrollment and study participation less burdensome for patients.
MASLD/MASH progresses slowly and successful treatment is often evaluated over a period of years. Because of that, researchers often use early signs—like changes in liver fat or inflammation—as trial endpoints. Increased development of reliable disease biomarkers holds the promise to predict long-term outcomes and facilitate regulatory approval.
