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a DNA test
The Food and Drug Administration said on Friday that it was moving to close what has widely been viewed as a loophole allowing certain lab tests — like those that determine the profile of a tumor or the genetic health of a fetus — to bypass review with virtually no tracking or oversight.

The agency proposed a rule that would bring the tests under its regulatory authority, requiring laboratories conducting them to provide data on test accuracy. Hundreds of tests on the market have very little oversight and may be misleading to the public and patients seeking to learn whether they have Lyme disease, Alzheimer’s or will develop cancer.

The proliferation of these tests “leaves Americans vulnerable to making important health care choices based on potentially faulty or inaccurate test results,” Dr. Robert Califf, the F.D.A. commissioner, said in a news briefing on Friday.

The tests, which included the first ones to detect Covid-19, have been subject to agency concern for 30 years and have been a perennial — yet essentially untouchable — target by lawmakers dating back to former...