Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing.

ABSTRACT:

Importance

The debate about the role of the Food and Drug Administration (FDA) in the regulation of laboratory-developed tests (LDTs) has focused attention on the analytical performance of all clinical laboratory testing. This study provides data comparing the performance of LDTs and FDA-approved companion diagnostics (FDA-CDs) in proficiency testing (PT) provided by the College of American Pathologists Molecular Oncology Committee.

Objective

To compare the analytical performance of LDTs and FDA-CDs on well-characterized PT samples and to compare the practice characteristics of laboratories using these assays.

Design, setting, and participants

This comparison of PT responses examines the performance of laboratories participating in the College of American Pathologists

SUBMITTER: Kim AS 

PROVIDER: S-EPMC6145687 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature