Novel biomarker tests have met or exceeded the performance of common lab tests for diagnosing nonalcoholic steatohepatitis (NASH, now known as metabolic dysfunction-associated steatohepatitis or MASH), laying the groundwork for noninvasive alternatives to liver biopsy, new research suggests.
The blood-based tests could expand diagnostic options at healthcare facilities and facilitate enrollment in NASH clinical trials, which now require a biopsy for inclusion.
“The current study meets a key milestone for qualification of the biomarker panels studied for identification of at-risk NASH,” Arun Sanyal, MD, of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, Richmond, told Medscape Medical News.
“It sets the stage for further validation of these outcomes,” he said. “These data will inform development of full qualification plans for these biomarker panels that will be submitted to the US Food and Drug Administration [FDA]. Once these are accepted by the FDA, the final steps toward qualification can be initiated.”