February 10, 2021 — Median Technologies announced the company has signed a research collaboration agreement with the University of California San Diego (UC San Diego) aimed at carrying out a study that will be used for its proprietary imaging platform iBiopsy validation. The study is related to the iBiopsy NASH Clinical Development Plan (CDP).
It is estimated that NASH is affecting 1.5-6.45 % of the global population. There is currently no cure for advanced stage of the disease and diagnosing the disease early can save patients' lives as NASH, in its early stage, is reversible through changes in eating habits and lifestyle. The clinical interest is therefore to distinguish accurately and non-invasively patients with early fibrosis from patients with advanced fibrosis at risk of progressing to cirrhosis and liver cancer. In this clinical context, the objective of Median's retrospective study with UC San Diego is to quantify the ability of iBiopsy®'s learning algorithms to discriminate between early and advanced fibrosis grade in NASH patients.
The study is led by Kathryn Fowler, M.D., Diagnostic Radiologist, Professor of Radiology at UC San Diego, as Principal Investigator. It will be conducted retrospectively on a cohort of 300+ patients. Median expects confirming the promising results on the NASH Clinical Development Plan, which were released in November 2020. First results of the Median-UC San Diego study are currently expected in Q1, 2022.
UC San Diego is known as a leading university and health care center in the US with worldwide recognition for their work in the field of liver disease, with a strong focus on NALFD and NASH. UC San Diego has been recently ranked #1 in the world for gastroenterology and hepatology (liver) research, based on physicians' research reputation and publications, by the US News and World Report.
Beyond the validation of Median's iBiopsy technology and its performance to discriminate between early and advanced fibrosis grade in NASH patients, this strategic collaboration with UC San Diego will help advance clinical research intended to improve NASH patient diagnosis and monitoring.
"Magnetic Resonance Imaging is well positioned to provide biomarkers for noninvasive diagnosis and longitudinal monitoring in patients with fatty liver disease," said Fowler. "The development and validation of these biomarkers is a primary focus of the Liver Imaging Group at the University of California, San Diego."
"We are delighted with this agreement between Median and UC San Diego. The University of California San Diego is the world largest university and health care center for liver diseases and has gained world recognition for the quality of its research and publications", said Fredrik Brag, founder and CEO of Median. "The development of a noninvasive biomarker to diagnose early NASH is critical for patients. There is currently no cure for advanced stage of the disease and diagnosing the disease early can save patients' lives. This major collaboration will complement our first validation steps in 2020 and support our go to market strategy," he added.
For more information: www.mediantechnologies.com