Active Genomes Expressed Diagnostics, Corp
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the assessment of liver fibrosis (scarring). MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) that can lead to advanced liver disease, cirrhosis and liver-related complications. This prospective, observational study will enroll approximately 400-500 patients with suspected MASLD who are undergoing liver biopsy as part of their clinical care. Researchers will collect blood samples and relevant medical information from participants at multiple clinical sites. The blood samples will be analyzed using advanced DNA sequencing technology to measure DNA methylation, a biological marker that may provide information about liver health. The study will evaluate how accurately the investigational blood tests distinguish MASH from simple steatosis (fat accumulation in the liver without MASH) and identify different stages of liver fibrosis. Blood test results will be compared with liver biopsy findings. The results will be used to select and validate the most accurate prediction models for future clinical utility studies. The long-term goal is to develop noninvasive blood tests that may help healthcare providers identify patients with MASH and liver fibrosis earlier and guide appropriate clinical care.
Study Overview: This multicenter, prospective, observational study is designed to validate investigational blood-based diagnostic tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the staging of liver fibrosis. MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) characterized by fat accumulation, inflammation and injury to liver cells. Over time, MASH can lead to liver fibrosis, cirrhosis and serious liver-related complications. Early identification of MASH and accurate assessment of…
Inclusion Criteria for MASLD \& Fibrosis Patients Patients must meet all the following inclusion criteria to be eligible for enrollment in the study: 1. Patient is between the ages of 18 and 75. 2. Patient understands and is willing to sign a written informed consent form (ICF). 3. Patient has been diagnosed with or is suspected of having MASLD, more specifically, either simple steatosis, metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction and alcohol-associated liver disease (MetALD), or a confirmed or suspected diagnosis of liver fibrosis and are being evaluate…