Letter to Office of Management and Budget supporting FDA regulation of laboratory-developed tests (LDTs)

Dear Administrator Revesz,

We, the undersigned organizations, are writing in support of the Food and Drug Administration (FDA) regulation of laboratory developed tests (LDTs) to ensure that patients and doctors are getting results that are accurate and clinically meaningful. LDTs have become increasingly important in clinical practice but put patients at risk and increase healthcare costs when they are inaccurate or are not supported by scientific evidence. Almost a decade has elapsed since FDA first proposed regulating LDTs in a draft guidance that was never finalized due to pressure from industry and Congress. Congress has repeatedly failed to pass legislation that would establish a regulatory framework for these tests, despite support from at least one industry trade group that represents many smaller LDT manufacturers. For this reason, FDA has proceeded with regulation.