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 Azeen Ghorayshi and Sarah Kliff, The New York Times | 08.12.2024
An emerging movement against in vitro fertilization is driving some doctors and patients in red states to move or destroy frozen embryos.
The embryo migration is most striking in Alabama, where the State Supreme Court ruled in February that embryos...
By Editorial Staff, The Lancet | 07.20.2024
Image by DrKontogianniIVF from Wikimedia Commons
Despite major advances in securing sexual and reproductive rights globally, one aspect is continually neglected: infertility. Evolving gender norms and financial precariousness have led to delayed childbearing, which increases infertility in both males and...
By Staff, AP-NORC | 07.12.2024
Image by Dr. Jayesh Amin from Wikimedia Commons licensed under CC by-SA 3.0
Most adults support protecting access to in vitro fertilization, or IVF, a type of fertility treatment where eggs are combined with sperm outside the body in a...
By Julia Black and Margaux MacColl, The Information [cites CGS' Katie Hasson] | 07.19.2024
When venture capitalist Jack Abraham first began dating his wife, Gabriella Massamillo, he insisted on one condition: that when they were ready to have children, she’d be willing to conceive using in vitro fertilization. Abraham had lost both his mother...