Genetic abnormalities may be caused by a missing chromosome or an extra copy of a chromosome, known as an aneuploidy, a small piece missing from a chromosome called a microdeletion, or an extra piece of chromosome called a duplication. They only provide information about the risk that a fetus may have a genetic abnormality, and additional testing may be needed to confirm whether or not a fetus is affected. However, NIPS tests are screening tests – not diagnostic tests. NIPS tests can provide information about the possibility a child will be born with a serious health condition. We 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.” “Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. “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 Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. Given the increased use of these tests and recent media reports, the FDA is providing this information to educate patients and health care providers and to help reduce the inappropriate use of NIPS tests. These tests look for signs of genetic abnormalities in a fetus by testing a sample of blood from the pregnant person.
Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT).
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