Factors Influencing Choice of Laboratory-Developed Tests and US Food and Drug Administration (FDA)–Approved or FDA-Cleared In Vitro Diagnostics for Molecular Analytes

This study highlights the primacy of performance for laboratories' selection of assays. The variability of laboratory preferences for LDTs and FDA IVDs illustrates the need for a regulatory approach that minimizes burdens and is flexible, so that laboratories can best adapt to their unique clinical environments. These preferences should be considered to reduce impact on laboratories and on patient care as the FDA and other agencies assess regulatory oversight.