Translational Data Inform a Scalable, Noninvasive Test Designed to Identify Treatment-Eligible Patients and Enable Longitudinal Assessment as MASH Therapies Expand
SAN DIEGO, CA / ACCESS Newswire / May 3, 2026 / Prometheus Laboratories Inc. ("Prometheus"), a leader in precision healthcare, today announced new translational research presented at Digestive Disease Week (DDW) 2026 supporting the development of a next-generation, blood-based approach designed to address a critical gap in noninvasive testing (NIT) for metabolic dysfunction-associated steatohepatitis (MASH).
Prometheus has been at the forefront of noninvasive liver fibrosis assessment for more than two decades. Its FibroSpect NASH test was developed at a time when noninvasive alternatives to liver biopsy were limited and disease-modifying therapies were not yet available. FibroSpect NASH addresses a pressing clinical need by helping identify patients at risk for advanced fibrosis and cirrhosis using an objective, noninvasive and longitudinally trackable score, supporting both risk stratification and ongoing disease assessment.
As the MASH therapeutic landscape has evolved, with treatments now directed toward patients with moderate fibrosis (F2-F3) and additional therapies under development, the diagnostic needs of health systems and clinicians continue to shift. Often asymptomatic, MASH affects up to 20 million people in the United States, with prevalence rising alongside obesity and type 2 diabetes, increasing the importance of timely, scalable and cost-effective identification of treatment-eligible patients and ongoing assessment of those receiving therapy with blood-based testing.
At DDW 2026, Prometheus is presenting findings from an exploratory, translational research study evaluating how its established FibroSpect biomarker architecture performs when applied to fibrosis staging ranges aligned with today's treatment-eligible MASH population. The analysis illustrates how interval-based scoring may help distinguish patients more likely to have moderate fibrosis (F2-F3) while helping rule out cirrhosis, providing clinically relevant insight.
"This work reflects how fibrosis assessment must evolve alongside the therapeutic landscape," said Rohit Loomba, MD, MHSc, lead author of the study, and Chief of the Division of Gastroenterology and Hepatology and Director of the MASLD Research Center at the University of California San Diego. "Interval-based interpretation can provide more nuanced information than a single cutoff and better aligns noninvasive assessment with clinical decision-making as therapies increasingly target patients with moderate fibrosis."
These initial findings demonstrate how translational research can inform diagnostic innovation for the MASH treatment era. Building on this work, Prometheus is developing a next-generation noninvasive blood test planned for launch later this year to support identification, management and risk stratification of treatment-eligible MASH patients.
Poster Su2029, "Non-Invasive Testing to Rule-In Moderate to Severe Fibrosis While Ruling Out Cirrhosis for Therapeutic Intervention in Metabolic Dysfunction Associated Steatohepatitis," will be presented at DDW 2026 on Sunday, May 3, at 12:30 p.m. CDT.
Dr. Loomba is a paid consultant and scientific advisor for Prometheus Laboratories.
About Prometheus Laboratories
Prometheus Laboratories has been a leader in diagnostic testing for gastroenterology and hepatology for more than 30 years. The company's portfolio of non-invasive diagnostic tests supports clinicians in the diagnosis, assessment and management of complex gastrointestinal and liver diseases, including inflammatory bowel disease and liver fibrosis. Prometheus is committed to advancing precision-guided diagnostics that help inform clinical decision-making and longitudinal assessment across evolving standards of care. For more information, visit the Prometheus website and follow us on LinkedIn or X (formerly Twitter).
About DDW
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 2-5, 2026. The meeting showcases nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
Media Contact
Chrystal Johnson
Sr. Marketing & Events Specialist
Prometheus Laboratories Inc.
marketing@prometheuslabs.com
SOURCE: Prometheus Laboratories Inc.
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