Lab 'validation' Vs Validation for regulatory approval.7 Feb 2025 08:15
One uses a limited sample size (typically a few hundred patients) and is a kind of screening trial to answer the question could this work? The latter has to demonstrate efficacy for a much much larger sample size (typically tens of thousands) with sufficient diversity to demonstrate efficacy for both semester, multiple ethnicities and all age ranges. It frequently involves randomised control trials and costs a lot of money.
OBD's tests are only laboratory 'validated'and this is why they are struggling to sell the 'flagship' CIRT test, the PSE and it is alsoʻ why the latest colerectal cancer test has a long road to travel before it can be successfully commercialised.