03/06/2019
https://congress.gov...
"It does not make sense to regulate tests differently based on who develops them."
"Patients deserve to know that the test results they are relying on to diagnose or treat a condition is accurate."
"So that is one of the dangers if you will."
"When you look at infrastructure, there are really three goals. How do you provide for clarity, consistency, and completion--the three C's of infrastructure."