Comparison of Laboratory-Developed Tests and FDA-Approved Assays for <i>BRAF, EGFR,</i> and <i>KRAS</i> Testing

Abstract

This study demonstrates the high degree of accuracy and comparable performance of both LDTs and FDA-CDs for 3 oncology analytes. More significantly, the majority of laboratories using FDA-CDs have modified the scope of their assay to allow for more clinical practice variety, rendering them LDTs. These findings support both the excellent and equivalent performance of both LDTs and FDA-CDs in clinical diagnostic testing.