FDA Warns of Risks Associated With Noninvasive Prenatal Screening Tests

The FDA is warning the public of the risk of false results, inappropriate use, and inappropriate interpretation of results with noninvasive prenatal screening tests (NIPS)—also called cell-free DNA tests or noninvasive prenatal tests.

These tests are offered without review by the FDA. The tests look for signs of genetic abnormalities in a fetus by testing a sample of blood from a pregnant person. The increased use of NIPS and recent media reports have prompted the FDA to provide this warning to educate patients and healthcare providers and to help reduce the inappropriate use of these tests. “While genetic non-invasive prenatal screening tests are widely used today,” the agency states, “these tests have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science.” People can make inappropriate healthcare decisions regarding their pregnancy based on the results of the tests. The FDA strongly urges patients to discuss the benefits and risks of NIPS with a genetic counselor or other healthcare provider prior to making decisions based on the results of these tests.

The FDA notes that the tests cited in the warning are screening tests, not diagnostic tests. They only provide information about the risk that a fetus might have a genetic abnormality, and additional testing could be needed to confirm whether or not a fetus is affected.

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