Non-Invasive Prenatal Screening May Come with Risks

FDA warns public about potential risks of non-invasive prenatal screening tests

(RxWiki News) Non-invasive prenatal screening (NIPS) tests may come with some risks.

That's according to a recent warning from the US Food and Drug Administration (FDA).

To be clear, the FDA isn't saying that these non-invasive tests — which usually involve nothing more than a blood draw and some testing in a lab — can harm a fetus directly. Rather, the FDA is warning that the results from these tests may be prone to misinterpretation.

And that can lead to improper medical decisions, the agency said.

“While genetic non-invasive prenatal screening tests are widely used today, 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,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy."

NIPS tests look for signs of serious health conditions caused by genetic abnormalities in unborn children. They are screening tests, the FDA noted — not diagnostic tests.

In other words, they only speak to the risk that a fetus will have a genetic abnormality. They don't confirm a condition or make any kind of diagnosis, which would require additional testing and review by a health care professional.

Although these tests are largely not FDA-reviewed, some labs that offer them advertise them as reliable and "highly accurate." These are claims, the FDA noted, that may not be supported by scientific evidence.

The FDA said that it would "strongly urge patients to discuss the benefits and risks of these tests with a genetic counselor or other health care provider prior to making decisions based on the results of these tests," according to an FDA press release.

Talk to your health care provider about which prenatal screening tests are appropriate for you, as well as how you should interpret the results.

Review Date: 
April 26, 2022