Orrin Hatch: “I fear that, as has been intimated, the current review process that the FDA has would not be adequate to accommodate all…”

“I fear that, as has been intimated, the current review process that the FDA has would not be adequate to accommodate all of the tests that fall under their definition of LDTs, and that without further refining the highest risk tests, there would not be an adequate infrastructure to expeditiously review these tests, delaying diagnoses and delaying innovations reaching the clinic.”