In recent years, the scientific community has made significant strides in the field of gene editing, particularly through the development of the CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) systems.
Lab test overhaul: FDA to regulate LDTs as medical devices
The Food and Drug Administration’s final rule solidifying its authority over laboratory developed tests (LDTs) marks a major shift in the regulation of the diagnostics