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

Key Points

• The research aims to understand what influences laboratories in choosing between laboratory-developed tests and FDA-approved in vitro diagnostics.
• Analysis of laboratory preferences in test selection
• Assessment of the impact of regulatory requirements on assay usage
• Evaluation of clinical environments influencing test decisions
• Performance is the primary factor in assay selection for laboratories
• Variability exists in preferences for laboratory-developed tests versus FDA-approved diagnostics
• Regulatory flexibility is suggested to better align with laboratory needs and patient care