The regulation for many diagnostics is actually fairly light. There's a class of diagnostics called "lab developed tests" that essentially aren't regulated by F

The regulation for many diagnostics is actually fairly light. There's a class of diagnostics called "lab developed tests" that essentially aren't regulated by FDA The development cost is high because you need good data to convince doctors that tests work, and also to convince payers. Payers have proven to be the real gatekeepers for many diagnostics rather than FDA