FDA warns public about inaccurate results of prenatal DNA tests | Life
Washington, D.C. — This week, the U.S. Food and Drug Administration made a public announcement warning the public about risks associated with non-invasive prenatal screening (NIPS) tests. The tests were put on notice for false results, inappropriate use, and incorrect interpretations of results.
The tests look for genetic signs that a fetus is at risk of being born with a serious health condition by testing a pregnant patient’s blood.
The tests are only intended for screening, not diagnosing any abnormalities; false positives and negatives are possible, and at times the tests may detect an abnormality in the placenta that does not exist in the fetus. Additional testing is required to confirm whether a fetus really has a genetic abnormality.
Patients are advised to discuss the benefits and risks of NIPS/NIPT tests with genetic counselors or other healthcare providers prior to making any significant decisions based on home test results. In particular, the FDA discourages deciding to terminate a pregnancy based on one of these tests.
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. Conditions caused by missing or extra chromosomes or chromosome pieces include Down syndrome or DiGeorge syndrome and may cause heart defects, feeding difficulties, immune system problems, and learning disabilities.
NIPS tests are not reviewed by the FDA; the FDA cannot guarantee the reliability or accuracy of any such tests.