Image: Non-invasive biomarker testing could be an alternative to painful liver biopsy (Photo courtesy 123RF)
Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH, is a serious disease. Once the liver begins to heal, the risk of cirrhosis, liver cancer, and death increases significantly. Unfortunately, symptoms of MASH often do not appear until the disease reaches its advanced stages, usually when cirrhosis has developed. Currently, the only way to diagnose MASH in patients is through liver biopsy. However, this method provides information about only a small part of the liver and does not provide an accurate overall assessment of the patient’s condition. Liver biopsy is also painful, invasive, and expensive for patients. Although some companies are developing blood biomarkers and imaging tests, none have met the rigorous requirements of FDA regulatory approval. Now, a consortium dedicated to researching non-invasive tests for liver diseases has achieved an important milestone by demonstrating the effectiveness of five of these tests, moving closer to regulatory approval.
The research is part of NIMBLE (Noninvasive Biomarkers of Metabolic Liver Disease Project) to evaluate blood and imaging biomarker tests for liver disease and was led by Virginia Commonwealth University (VCU, Richmond, VA, USA). The NIMBLE biomarker tests were rigorously compared to established measures, including the FIB-4 index, used to assess liver health. Any biomarker test that matched or exceeded the performance of existing laboratory tests was evaluated for potential use in the diagnosis of MASH and related conditions. More than 1,000 patients participated in this research. These five biomarker tests show promise in diagnosing MASH and related conditions, and provide a non-invasive alternative to liver biopsy. This development is expected to encourage patient participation in future clinical trials that would otherwise require invasive liver biopsy. Furthermore, the use of non-invasive blood tests could significantly reduce the cost of conducting such studies, which would lead to greater interest in drug development. What is equally important is that these tests can be easily performed in a doctor’s office.
“This brings us one step closer to a simple blood test that can be ordered in virtually any clinical setting and that will provide patients access to care,” said Professor Arun Sanyal, MD, VCU School of Medicine. Will do.” “Such a step will help our ability to identify those at highest risk for outcomes and provide them with targeted therapy. “It will also serve as a basis for the development of biomarkers for prediction, disease monitoring and response to treatment.”
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