Clinical Diagnostic Validation of the LiverFASt Test and the Associated Fibrosis Staging Scores for Activity/Inflammation and Steatosis as Compared to Liver Tissue Pathology Via Liver Biopsy

Chronic liver diseases (CLDs), such as chronic viral hepatitis, nonalcoholic fatty liver diseases (NAFLD) and nonalcoholic steatohepatitis (NASH), are a leading cause of morbidity and mortality globally and usually develops over many years. The prevalence of NAFLD has increased in recent years (15% in 2005 to 25% in 2010). As, approximately 20% of NAFLD cases develop NASH, the associated increase in NASH during the same period is to be expected (33% in 2005 to 59.1% in 2010).

The risk of liver-related mortality increases exponentially with increase in fibrosis stage. As the progression from NAFLD to NASH is associated with progressive liver fibrosis, the prognosis for NASH is worse than it is for NAFLD, and results in an increased risk of cirrhosis, hepatocellular carcinoma (HCC) and death from liver related causes. As a result, staging of liver fibrosis is essential in determining the prognosis and optimal treatment for patients with NASH. Furthermore, evaluation of fibrosis in NAFLD patients can help refine treatment options designed to prevent the progression to NASH. Currently, liver biopsy is the gold standard for staging liver fibrosis. However, liver biopsy is invasive, expensive and prone to sampling error. Developing, safe and easily accessible noninvasive modalities to accurately evaluate fibrosis stage of NAFLD and NASH is of utmost importance in clinical practice. The use of non-invasive biomarkers of liver fibrosis are needed in the general population setting.

LiverFASt is a non-invasive diagnostic and staging tool, which has been developed as an alternative to liver biopsy. It is a reliable, and reproducible tool which provides grading or staging of the three elementary features of NASH: steatosis, inflammatory activity and fibrosis. The main aim of this study is to evaluate the diagnostic value of LiverFASt as a non-invasive biopsy-proven assessment of fatty liver disease.

Early liver disease detection allows patients treatment options for a healthier and productive life. Once liver disease progresses to cirrhosis or cancer, treatment options are limited and expensive. Reducing the almost $2Billion dollar liver disease economic burden to the United States, requires a breakthrough technology, which brings diagnosis to the patient.

Current liver disease diagnosis devices are dependent on fixed facilities, which utilize ultrasound, CT scan, MRI or biopsy sampling with pathology analysis. The dependency on fixed facility diagnostic procedures introduces barriers to patients receiving early detection. While it is known that early detection, wellness and cost effectiveness mitigate these realities, and many trends today in diagnostics are pushing greater early access to the patients, providers limit screening and detection to patients for which the procedure meets the cost-benefit in the ever-evolving value-based healthcare system. Additionally, requiring patients to travel to radiology or laboratory facilities introduces adherence issues.