Highlights

• A biopsy is a very important tool for the staging of the disease, but I must highlight that at least in our US practice it is used only in a minority of patients at routine clinical practice because of the invasive nature of the test, and the potential for discomfort and pain, and for potential severe adverse effects, such as bleeding. 
• With new therapies that are emerging it is widely expected that there will be a requirement for a liver biopsy to confirm and stage the disease, to confirm the eligibility of a patient with a new treatment. New treatments are focusing on those with not only fatty liver actually, but NASH with inflammation and at least stage 2 fibrosis, and as such there’s going to be a requirement by insurance companies for a biopsy before they will authorize the coverage of a new medication, and that will be required by the FDA, by clinical guidelines, by our liver society, and by insurance companies, and yes, that will directly influence the decision to pursue liver biopsy on a more routine basis. 
• For fat we have very good non-invasive tools, there’s a quality of tests like ultrasound, CT scan, MRI, on a yes/no basis it’s pretty good. However, the sensitivity is less than optimal because you must have at least 30% infiltration of liver tissue with fat before it’ll be picked up on an ultrasound. On the other end of the scale we have reasonable reliable tools for fibrosis based on what we just discussed, including the serum tests and elastography, FibroScan, and MRI, they’re not perfect, but they’re pretty good, especially for those patients who have advanced liver disease. However, for that middle piece of NASH with inflammation, we do not have a reliable non-invasive test. Now, for fibrosis there’s still room for improvement, and so there are many other newer tests that are emerging, two of which are better known clinically, NIS4, and PRO-C3, so those are emerging but the idea is that we already have reasonably reliable tools for fibrosis, but not for inflammation.