The U.S. Food and Drug Administration (FDA) has released a safety warning to patients and health care providers regarding genetic non-invasive prenatal screening (NIPS) tests. These tests have been found to give false results that have resulted in misinformed decisions about the health of the pregnant person and the fetus.
On April 19, the FDA warned that NIPS tests can provide false test results to patients and health care practitioners. NIPS tests work by taking a portion of the parent’s blood at a time when the fetal DNA can be detected. This DNA is examined for chromosomal or genetic abnormalities that may indicate future health problems.
According to the FDA, “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.”
The FDA acknowledged that the use of NIPS tests is widespread among health care providers despite the fact that no NIPS tests “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.”
The agency is quick to point out that, as a screening test, NIPS tests do not have any diagnostic capability and a follow-up test is required to confirm the presence of an abnormality.
In their safety announcement, the FDA stated that the agency was “aware of reports that patients and health care providers have made critical health care decisions based on results from these screening tests alone and without additional confirmatory testing” including people who “ended pregnancies based only on the results of NIPS tests.” The Agency also cited cases in which a NIPS test reported a fetus would develop an abnormality but confirmation testing actually proved that there was no issue with the fetus.
In light of recent media reports regarding the use of NIPS tests, the FDA has stated a few courses of action for patients and health care providers. Patients are advised to discuss the benefits, or risks, of using NIPS tests with a genetic counselor or healthcare provider and consult with them after receiving the NIPS test results before making a decision about the pregnancy.
The FDA has cautioned health care providers to be aware of the risks and limitations of NIPS tests. The agency stressed that NIPS tests are not enough to diagnose chromosomal abnormalities or disorders.