Devices

Warning on Genetic Prenatal Screening Tests

FDA has issued a warning about the risks of false results with genetic non-invasive prenatal screening (NIPS) tests. The tests provide information about the possibility of a fetus having certain genetic abnormalities that could result in a child being born with a serious health condition, an FDA release says, adding that the tests have not been authorized, cleared, or approved by the agency.

The agency warning notes that pregnant people have ended pregnancies based only on the results of NIPS tests. “Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” it says. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

FDA recommends that patients discuss the tests’ benefits and risks with a genetic counselor or other health care provider before deciding to get a test. “Health care providers should be aware of the risks and limitations of using these screening tests and should not use the results from these tests alone to diagnose chromosomal (genetic) abnormalities or disorders,” the warning says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome