F.D.A. Warns Patients About Some Prenatal Genetic Tests


The Food and Drug Administration warned expectant parents on Tuesday about the risk of false positive results from a booming line of prenatal blood tests that screen fetuses for rare genetic conditions.

The notice followed a New York Times examination in January that reported on the incidence of false positive results in some of these tests, known as noninvasive prenatal screening tests, or NIPTs. That article quoted women who received false positive screening results for extremely rare conditions; highlighted examples of misleading marketing by companies selling the tests; and described some reports of pregnancies that were terminated based on a screening without a confirmatory test.

The agency warned doctors not to diagnose genetic disorders based on these results alone and stressed the need to follow positive screenings with more reliable “diagnostic” testing. It said it was “aware of reports” that some women “have ended pregnancies based only on the results” of these genetic screening tests.

“While genetic noninvasive prenatal screening tests are widely used today, these tests have not been reviewed by the F.D.A. and may be making claims about their performance and use that are not based on sound science,” Dr. Jeff Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a statement.