Federal Oversight of Laboratory-Developed Tests

To the Editor: In their Perspective article, Singhal and colleagues (Nov. 9 issue)(1) support the proposed Food and Drug Administration (FDA) rule that would end the agency's enforcement-discretion policy for laboratory-developed tests. The authors cite the proliferation of commercial tests without clinical utility. Most laboratory-developed tests are used internally to support the care of hospitalized patients when FDA-cleared tests are unavailable. The authors speculate that lobbying by academic medical centers against the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022 was financially motivated. In reality, laboratories at academic medical centers do not generate revenue. The authors suggest that the . . .