Home 5 Articles 5 NIPS Tests Are under Fire Again—This Time from the FDA

NIPS Tests Are under Fire Again—This Time from the FDA

by | Apr 21, 2022 | Articles, News, Open Content

With increasing media coverage about problems with genetic non-invasive prenatal screening, the agency warns of risks of false results.

Genetic non-invasive prenatal screening (NIPS) tests, which are used to determine the chances a child may be born with serious health issues due to genetic abnormalities, are under fire again, this time from the U.S. Food and Drug Administration (FDA). The agency released a Safety Communication on April 19 warning both health care providers and patients about the risks of false results from these tests.

This isn’t the first time such concerns surrounding NIPS tests have been raised. Performance and accuracy issues with the tests, also known as noninvasive prenatal testing or tests (NIPT), have been a concern for a while, but became more widely known to the public when a New York Times piece about such issues was published in January 2022.

How the tests are marketed has also been a concern for health care experts. While NIPS are not diagnostic tests and only screen for the risk of genetic abnormalities that may cause a child to be born with severe health issues, NIPS are often portrayed to patients as highly accurate, definitive tests. Because of this, pregnant women may go through additional stress and more invasive testing only to find out that their unborn child is perfectly healthy. In more extreme cases, some women may choose to end their pregnancy based only on the results of NIPS tests, the FDA adds in its Safety Communication.

The FDA points out that, while NIPS tests are commonly used among health care providers, none have yet received authorization, clearance, or approval from the agency. The agency has also not evaluated the performance and accuracy of these tests. With the problems surrounding the tests gaining more media coverage, the FDA recommends that patients consult with their health care provider or a genetic counselor to better inform themselves of the pros and cons of NIPS tests. The FDA stresses to both health care providers and patients that NIPS results should never be used to make major decisions about a patient’s pregnancy.

Because such tests are laboratory developed tests (LDTs), how they are marketed and offered to the public is not currently regulated by the FDA and, though LDTs are considering medical devices under current legislation, the agency doesn’t enforce applicable regulatory requirements for most of these tests, the FDA says.

“The FDA is continuing to work with Congress on legislation to establish a modern regulatory framework for all tests, including LDTs,” it says in the April 19 Safety Communication.