Congress must act now to protect the future of diagnostic tests

Anne Thompson

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By Walter G. Johnson

Nov. 15, 2024

Johnson is a postdoctoral fellow at the Center for Law and the Biosciences at Stanford Law School.

The 2024 election results will have vast consequences for health policy, but one of the less visible effects will be to once again disrupt how the federal government regulates diagnostic tests.

Clinical tests are vitally important to patients and providers because test results often guide our decisions about health and treatment plans. Yet, for decades now, regulation for diagnostics has been unclear and contested — a trend that appears likely to continue with an incoming Trump administration. To protect patients and give test developers a clearer regulatory environment, Congress should pass bipartisan legislation on diagnostics called the VALID Act that it has been discussing since 2018.

Part of the issue stems from a nearly 50-year-old policy distinction between two types of diagnostic tests. The FDA already regulates tests that are made by one developer and sold as a “kit” to be used elsewhere, such as in a clinic or hospital setting, as well as those sold directly to consumers. But some of the most advanced and complicated diagnostics are done in-house at individual hospitals or laboratories, rather than sold to others as kits. These are often called laboratory-developed tests, or LDTs.

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