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Doctors and patients rely on in vitro diagnostics (IVDs)—tests on human samples such as blood, saliva, or tissue—to guide treatment for a wide range of conditions, from cancer to COVID-19. However, a decades-old policy is allowing an unknown number of high-risk tests to enter the market without approval from the Food and Drug Administration (FDA) if the tests are developed and used in the same lab. Furthermore, labs are not required to report when their lab-developed tests (LDTs) deliver inaccurate results that harm patients.

To gauge public perceptions of this issue, The Pew Charitable Trusts commissioned a nationally representative survey of 808 adults and a moderated online discussion board of 37 adults to examine how often people have received inaccurate tests and their impression of testing regulations.

Most participants expressed support for reform that would increase FDA’s oversight of LDTs. The Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021 provides lawmakers with a solid foundation to achieve this goal. Congress should work with other stakeholders to address outstanding issues and pass legislation that ensures all diagnostic tests are safe, accurate, and reliable.

1 in 10 Americans who have received a test resulting in inaccuracy

Approximately 10% of those who have received a result from an IVD reported receiving an inaccurate result, which may mean that nearly 20 million adults in the U.S. have received inaccurate test results.⁶ More than half of those who reported inaccurate results discovered them either through a doctor or medical professional, or because they experienced an illness or symptom that contradicted the test results.

Over 50% of Americans report having taken a COVID-19 test

Under its public health emergency powers issued during the pandemic, however, FDA was able to require review of any test used to diagnose COVID-19, including LDTs. This allowed the agency to ensure that the tests on the market were sufficiently accurate and reliable. It also allowed FDA to take steps to remove any tests that later proved unreliable.⁸ In the same Pew survey, approximately 60% of respondents reported taking a test to diagnose if they are or have been infected with COVID-19. Over 90% of those who took a COVID-19 test reported “some” or “a lot” of trust in the test’s accuracy, though it is unclear what role FDA review played in instilling confidence.

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