Echosens, a high-technology company offering the FibroScan family of products, today announces the publication of the “FibroScan-AST (FAST) Score For The Non-Invasive Identification Of Patients With Non-Alcoholic Steatohepatitis With Significant Activity And Fibrosis: A Prospective Derivation And Global Validation Study,” in The Lancet Gastroenterology & Hepatology. FAST is a tool—available on the myFibroScan app—to help clinicians cost-effectively identify individuals at risk for active fibrotic non-alcoholic steatohepatitis (NASH), an asymptomatic, progressive and burgeoning liver disease that can lead to increased liver-related mortality and morbidity. The FAST Score is a combination of three components: two physical biomarkers: liver stiffness by VCTE™ and CAP™, estimating fibrosis and steatosis from an examination with FibroScan, plus AST, a readily available blood marker of inflammation. NAFLD affects approximately 25% of the worldwide population and as many as 6% are affected by NASH. NASH prevalence is expected to increase by 63% by 2030.
First author, Dr. Phil Newsome, University of Birmingham Professor of Experimental Hepatology, University Hospitals Birmingham NHS Foundation Trust Consultant Hepatologist, Director of the Centre for Liver and Gastrointestinal Research, Director of the Midlands and Wales Advanced Therapy Treatment Centre, and Deputy Director of the NIHR Birmingham Biomedical Research Centre, says, “Based on this prospective study including 1,400 patients undergoing a liver biopsy, this publication demonstrates the value of FAST as a tool to enhance the diagnostic capabilities of healthcare providers to efficiently identify patients with a high probability of active fibrotic NASH. With these study results, FAST emerges as a vital tool for cost effectively and efficiently identifying the 12.2 million people in the United States and European Union who may be living with active, asymptomatic fibrotic-NASH.”
Senior author Dr. Stephen A. Harrison, M.D., FACP, FAASLD, retired COL, USA, MC, visiting professor of Hepatology, Radcliffe Department of Medicine, University of Oxford, and medical director, Pinnacle Clinical Research, points to the study as very timely and significant because the efficient identification of active fibrotic NASH has long been a challenge for drug companies, with many now developing drugs that target this health crisis.
“In clinical trials to develop NASH drugs, over 50% of patients fail to meet the inclusion criteria, with the majority not having active fibrotic-NASH,” continues Harrison. “As treatments become available for active fibrotic NASH, FibroScan and tools like FAST support diagnosis efficiency at the point of care, improving diagnostic accuracy and reducing costs. FAST is inexpensive, reducing unnecessary, invasive assessments and the need for expensive, complex blood tests. It’s simple to determine and interpret – requiring just three numbers entered into a calculator on the myFibroScan app. Furthermore, the clinician can set the threshold for referral based on their goals, balancing sensitivity vs. specificity.”
The FibroScan examination is a simple, non-invasive test that provides biomarkers that can be used to diagnose and monitor liver health, providing immediate results for the treating clinician.
According to Dominique Legros, CEO of Echosens Group, “FAST is a great advancement for FibroScan- based models of care and represents the first of many scores where the FibroScan physical biomarkers will be combined with circulating biomarkers to enhance assessment and monitoring of liver health. We look forward to working with our colleagues in the pharmaceutical industry to identify and validate new combinations to enhance non-invasive monitoring of liver health, both for patients undergoing treatment and for those at risk of developing chronic liver disease.”
Echosens, the world’s number one provider of non-invasive medical devices dedicated to assessment of chronic liver diseases, pioneered the field of elastography technology by developing FibroScan®, the first device that quantifies liver stiffness non-invasively by using patented and validated VCTE™ for liver fibrosis assessment, and CAP™ for steatosis quantification. Significantly changing the practice of liver diagnosis, FibroScan® is recognized worldwide as the reference for non-invasive liver diagnosis with more than 2,500 medical publications and 40 guideline recommendations. Visit www.echosens.com to learn more.
About the University of Birmingham
The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
About The National Institute for Health Research (NIHR)
The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research. The NIHR:
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The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government.