Health care providers often base diagnosis and treatment decisions on information from in vitro diagnostics (IVDs), which analyze blood, tissue, and other human samples. These tests must produce accurate and meaningful results; otherwise, patients may receive delayed, inferior, or even unnecessary medical care.
The Food and Drug Administration (FDA) reviews many IVDs to verify their accuracy and ensure that a test’s benefits outweigh its risks. However, the agency has historically exempted diagnostics developed and used within the same laboratory from this oversight process. These lab-developed tests have become widespread and increasingly complex, exposing more people to potential harm from unreliable or misleading results.
Pew conducted research on the market for diagnostic tests and advocated for legislation that would subject these products to FDA review based on their risks to patients, not where they were made.