PharmaNest, NIH, and VCU Collaborate on AI-Driven Study for Liver Disease Prognosis

What's Happening?

PharmaNest Inc. has announced a collaborative research initiative with Virginia Commonwealth University (VCU) and the National Institutes of Health (NIH) to evaluate the effectiveness of AI-powered digital pathology biomarkers in metabolic dysfunction-associated steatotic liver disease (MASLD). The study involves a retrospective cohort of 1,765 patients with metabolic dysfunction-associated steatohepatitis (MASH) and aims to confirm the prognostic value of PharmaNest's FibroNest Ph-FCS biomarker. This biomarker provides a high-resolution, AI-driven fibrosis continuous score to predict hepatic decompensation. The study will compare this biomarker against traditional fibrosis staging and non-invasive tests, using anonymized digital pathology liver biopsies from the NAFLD Adult Database 2.

Why It's Important?

This collaboration is significant as it seeks to establish robust histological biomarkers that can guide patient management and accelerate drug development in MASLD. The integration of AI in digital pathology could enhance the accuracy and efficiency of diagnosing and monitoring liver diseases, potentially leading to better patient outcomes. The study's findings could pave the way for regulatory-grade digital biomarkers, offering a new standard in liver disease diagnostics and treatment. This advancement could benefit healthcare providers by providing more precise tools for assessing fibrosis progression and treatment responses, ultimately improving patient care.

What's Next?

The study will proceed with the processing of liver biopsy images and the generation of biomarkers, which will be integrated into a secure database for analysis. VCU will oversee governance and compliance, while NIH will provide clinical oversight. The results are expected to be delivered within the 2025 timeline, potentially influencing future clinical practices and regulatory standards in liver disease management.