LDT vs FDA-Approved Companion Diagnostics
LDT vs FDA-Approved Companion Diagnostics Comparing Laboratory Developed Tests and FDA-Approved Companion Diagnostics Introduction: Two Diagnostic Pathways in Precision Medicine In the realm of personalized medicine, companion diagnostics (CDx) are essential tools that identify patients likely to benefit from specific therapies. These diagnostics can be developed as Laboratory Developed Tests (LDTs), performed in CLIA-certified laboratories,…