FDA Issues Warning on Prenatal Genetic Tests

By Kristina Fiore: For Complete Post, Click Here…

Relying on results could lead to inappropriate medical decisions, agency warns.

The FDA warned in a safety communication that non-invasive prenatal tests (NIPT) are screening tests — not diagnostic tests — and patients and healthcare providers may make inappropriate healthcare decisions based on their results.

The agency said it’s aware of reports that people have made such decisions using the results of these tests without additional confirmatory testing.

“Pregnant people have ended pregnancies based on the results of genetic prenatal screening alone, without understanding the limitations of the screening test and that the fetus may not have the genetic abnormality identified by the screening tests,” the agency stated in a press release.


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