Research in support of novel blood-based testing
MASH Clinical Evidence
Labcorp’s leadership position in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH) is highlighted by scientific innovation in the blood-based identification of at-risk MASH. With our deep biopharma experience, we provide a customized approach to biomarker solutions in drug discovery that supports decision-making from discovery to the clinic.
Publications
Harrison SA, Ratziu V, Boursier J., et al. A blood-based biomarker panel (NIS4) for non-invasive diagnosis of non-alcoholic steatohepatitis and liver fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020;5(11):970-985. doi:10.1016/S2468-1253(20)30252-1.
Harrison SA, Ratziu V, Magnanensi J, et al. NIS2+™, an optimization of the blood-based biomarker NIS4® technology for the detection of at-risk NASH: a prospective derivation and validation study. J Hepatol. 2023;79(3):758-767. doi:10.1016/j.jhep.2023.04.031.
Sanyal AJ, Magnanensi J, Majd, et al. NIS2+™, an effective blood-based test for the diagnosis of at-risk nonalcoholic steatohepatitis in adults 65 years and older . Hepatol Commun. 2023;7(9):e0223, doi:10.1097/HC9.0000000000000223
AASLD 2023 Product Theater
We leverage the latest in blood-based biomarker technology to effectively detect patients at risk of developing metabolic dysfunction-associated steatohepatitis. Learn how these biomarker solutions are supporting decision-making across the healthcare continuum.
Posters and Abstracts
Ratziu V, et al. NIS2+ technology for early detection of fibrosis progression in patients with liver biopsy-proven at-risk NASH and F2. AASLD, 2022.
Ratziu V, et al. NIS2+ technology as a potential screening tool for enrollment of patients with at-risk NASH in clinical trials. AASLD, 2022.
Ratziu V, et al. Detecting MASH resolution and fibrosis improvement with NIS2+ ® in patients with at-risk MASH.AASLD, 2024.
Ratziu V, et al. NIS2+ ®, an effective monitoring tool for tracking disease evolution in patients with fibrotic MASH.AASLD, 2024.
Ratziu V, et al. NIS2+ ®, an effective tool for monitoring MASH resolution and fibrosis improvement in patients with at-risk MASH. AASLD, 2024.
Ratziu V, et al. NIS2+ ®, improves secondary risk assessment for referring patients at risk for or with established MASLD to specialists. AASLD, 2024.
Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE)
Led by the Foundation for the National Institute of Health’s Biomarkers Consortium, the goal of the NIMBLE program is to test the performance of currently available, well-validated, non-invasive MASH tests and provide evidence of clinical utility.
Stage 1 publication: The data supported the further development of NIS4® for its intended use to identify persons with at-risk MASH (nonalcoholic fatty liver disease activity score ≥4, liver fibrosis F≥2).
MASH guidance from health organizations
A number of health organizations have issued guidance, guidelines and/or recommendations regarding the diagnosis of and treatments for MASH. The following documents are provided for informational purposes.
- U.S. National Institutes of Health (NIH)
- American Diabetes Association (ADA) Standards of Medical Care 2023
- American Association of Clinical Endocrinology (AACE) Guidelines on NAFLD
- AGA Section Clinical Care Pathway
- American Association for the Study of Liver Diseases (AASLD) Practice Guideline
- Expert Committee on NAFLD (ECON) and the North American Society of Pediatric
- Gastroenterology, Hepatology and Nutrition (NASPGHAN) Clinical Guidelines