(WKBN) – The U.S. Food and Drug Administration is working to educate parents and health care providers about the inappropriate use of some non-invasive prenatal tests (NIPS tests).

NIPS tests look for signs of genetic abnormalities in a fetus by testing a sample of blood from the pregnant woman.

False results and flawed interpretation of the results can potentially lead to improper medical decisions, FDA officials said.

“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.”

NIPS tests are screening tests — not diagnostic. 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, FDA officials wrote.

All NIPS tests on the market today are offered as laboratory developed tests (LDTs). Most LDTs, including NIPS tests, are offered without review by the FDA.

According to the FDA, many laboratories market the tests as “reliable” and “highly accurate,” and offer “piece of mind.” However, the FDA says it is concerned that these claims may not be supported with “sound scientific evidence.”

Patients and health care providers are being urged by the FDA to be aware of the limitations of the tests and that they should not be used alone to diagnose genetic abnormalities.