Genetic Non-Invasive Prenatal Screening Tests May Have False Results
By Safety Communication,
FDA
| 04. 19. 2022
The U.S. Food and Drug Administration (FDA) is warning patients and health care providers about the risks of false results with genetic non-invasive prenatal screening (NIPS) tests, sometimes called noninvasive prenatal testing or tests (NIPT). Results from NIPS tests can 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.
While health care providers widely use NIPS tests, none have yet been authorized, cleared, or approved by the FDA. The accuracy and performance of NIPS tests have not been evaluated by the FDA and these tests can give false results, such as reporting a genetic abnormality when the fetus does not actually have one. NIPS tests are screening tests, which means the NIPS test may only tell you the risk of the fetus having certain genetic abnormalities. They are not diagnostic tests, which are generally used to more definitively confirm or rule out a suspected genetic abnormality.
The FDA is aware of reports that patients and health care providers have made critical health care...
Related Articles
By Jennifer Denbow, Guest Contributor
| 10.29.2026
Almost every day I am reminded that we are in the midst of a fertility panic. Whether it’s the Vice President exhorting Americans to have more babies or The New York Times running yet another story about the fertility cliff, fear about falling fertility rates is everywhere. While centrally concerned with declining rates of childbearing, Anna Louie Sussman’s new book, Inconceivable: The Impossibility of Family in an Age of Uncertainty, is a welcome antidote to the panic.
Sussman has written...
By Anna Louie Sussman, The New Republic | 10.26.2026
There’s a certain kind of novel that’s not quite apocalyptic enough to be science fiction, but just far-fetched enough to be speculative. No one is from outer space; society has not yet been carved up into a hierarchy of groups...
By Jan Grue, The Guardian | 10.27.2026
For a very long time, I dreamed of being cured. I was born in 1981. I learned to walk early enough, but I stumbled and fell more easily than other children. My parents began to worry that something was wrong...
By staff, We Are Egg Donors | 10.21.2026
Michelle Lambrechts is a police officer and one-time egg donor in Belgium. She is also the founder of Ik Zit Met Een Ei, a Belgian nonprofit that advocates for egg donors. (The name is a Dutch play on words...
