Considerations for Strategy, Regulatory Requirements, Implementation & Commercialization of a NASH CDx Assay
Time: 11:30 am
day: Day 1 Track C AM
Details:
- The global prevalence of Nonalcoholic steatohepatitis, or NASH, is increasing with over 5% of the general population affected. If untreated, NASH may progress to liver cirrhosis, liver carcinoma, and death
- Numerous risk factors influence the development of NASH, including genetic predisposition. We initiated an investigational trial for a hepatocyte-targeted siRNA approach in NASH
- A clinical trial assay is used to screen patients for a precision-medicine-based approach. This presentation will cover challenges related to implementing a screening test for patient enrollment in our trial
- We will review the CDx strategy, regulatory requirements, diagnostic development process (including commercial considerations), and the implementation of the clinical trial assay
