FDA Urges Caution on OTC Genetic Tests

OTC genetic tests have the potential to provide valuable information to patients, but their entry to market has been sluggish due to concerns about safety and reliability. A consensus reached in early March by the FDA’s Molecular Clinical Genetics Panel could slow the process even further.

The panel determined that the risks of selling genetic tests directly to consumers without a prescription may outweigh the benefits. At the very least, panelists agreed that most tests—and especially tests with high predictors of serious conditions such as heart disease or Alzheimer’s—should involve a physician at some point.

The panel did not determine the precise nature of that involvement, which would depend largely on the test in question. Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics, told reporters that “we’re not going to be able to take one approach to all types of tests.”

He said some may not require a physician at all, whereas others would require a physician to order the test, interpret the results, or both. Based on the FDA’s summary of the panel discussion, the former category is comparatively small, and includes lowstakes nutrigenetics tests with several caveats, such as whether the test is clinically valid.

At a public hearing, the panel also heard testimony from individuals. Many echoed the panel’s concerns that test results could be easily manipulated or misinterpreted. Others, including former FDA deputy commissioner Mary Pendergast, argued that withholding the tests from consumers is “paternalistic,” and that patients are entitled to freely access to their personal genetic information.