It is widely accepted that early cancer detection improves treatment options and increases 5 year survival. Once a cancer is symptomatic it is often late stage, so the major challenge is our ability to detect cancer in asymptomatic individuals. However, there is a major hurdle: for tests to have utility in this field they need to be validated in extremely large clinical trials - e.g the National Lung Screening Trial required 50,000 volunteers over 9 years - larger than any phase 3 multinational drug trial.
Despite the size of the investment needed to validate a screening test, the resulting product must then be low priced to make it affordable in a screening setting. The standard routes to market for IVDs don’t apply because the adoption hurdle is so high.
Globally, more funding is being targeted at early cancer detection biomarkers, but without a clear route to market and new business models, these efforts could fail to have any impact on healthcare outcomes.
Ability Level: Intermediate
Session ID: 503501