Amid Competing LDT Regulatory Proposals, Common Ground but Key Disagreements for Congress to Consider


Paul Radensky, who represents the Coalition for 21st Century Medicine, said the group « does not support risk-based classifications that identify algorithms or technological features as the basis for assigning risk” in regulating laboratory developed tests (LDTs). The coalition supports a risk-based regulatory framework under FDA that recognizes the differences between clinical diagnostics and medical devices, Mr. Radensky added, noting that current proposals to the contrary still need « substantial work.”