Fixing How FDA Regulates Diagnostic Lab Tests
The Food and Drug Administration (FDA) recently announced its intention to begin to regulate a class of medical laboratory tests called laboratory developed tests (LDTs). But before it embarks on new regulatory initiatives, the FDA should fix the significant deficiencies in its oversight of the laboratory tests that are already within its jurisdiction.
Precision medicine is often defined as providing “the right drug, for the right patient, at the right dose, at the right time.” That typically means performing genetic analysis on a patient’s blood or a tumor, and linking therapy to the identified genetic profile. Diagnostic laboratory tests are at the center of this process.
In the U.S., diagnostic laboratory tests are either LDTs or in vitro diagnostic test kits (IVDs). IVDs, manufactured and sold to laboratories, are regulated by the FDA. LDTs, on the other hand, are developed and performed within laboratories by skilled professionals for use with their own patients. They are overseen directly by the Centers for Medicare & Medicaid Services’ Clinical Laboratory Improvement Amendments program; by accrediting agencies like the College of American Pathologists; or by individual states.
But now the FDA plans to directly regulate LDTs. That would be a mistake.