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April 26, 2022

FDA Warns Against Using Inaccurate, Unapproved Prenatal Tests to Decide Abortion

A statement released by the Food and Drug Administration (FDA) on April 19 warns against the use of non-invasive prenatal screening tests as a determining factor for the decision to abort a child.

“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. “Without proper understanding of how these tests should be used, people may make inappropriate health care decisions regarding their pregnancy. 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.”

The statement goes on to say, "...when screening for a very rare condition, a positive screening result may be more likely to be a false positive than a true positive, and the fetus may not actually be affected. In other cases, a positive screening result may accurately detect a chromosomal abnormality, but that abnormality is present in the placenta and not in the fetus, which may be healthy. "

The FDA expressed concern that patients are using the results of non-invasive prenatal screening to make decisions such as abortion.

In a more detailed post created by the FDA to coincide with its press release, it explained that non-invasive prenatal screening tests do not diagnose conditions such as down syndrome. Positive tests are supposed to show that a child has a greater risk of genetic abnormality compared to average. Negative tests show a lower-than-average risk.

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