FDA-Cleared versus Laboratory-Developed Tests: Why Start from Scratch When Kits Are Available?

One of the most common questions facing laboratories when bringing up new clinical tests is deciding which specific assay best suits the needs of the lab, its patients, and its providers. At first glance, assays cleared by the Food and Drug Administration (FDA)2 for use in clinical testing would seem to have some obvious advantages: the validation requirements are less onerous than for laboratory-developed tests (LDTs) (1), and much of the legwork, e.g., sensitivity and specificity testing, is done by …