Health Affairs July 3, 2023
Laboratory-developed tests (LDTs) constitute a class of diagnostic in vitro tests that are designed, manufactured, and used within a single laboratory. The Food and Drug Administration (FDA) has long viewed the oversight of the safety and effectiveness of LDTs as part of its regulatory mission. However, the scope of this FDA responsibility has been the subject of continuous evolution and contention during which the agency exercised regulatory discretion.
The issue has come into sharper focus in recent years as, the Congressional Research Service describes, “genetic testing has become increasingly available for direct purchase by consumers, generally over the internet, often without the involvement of a health care provider and for increasingly complex and common diseases (e.g., cancer).” Furthermore, there is...
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