Risks associated with noninvasive prenatal tests: FDA warning

The press release states: “Pregnants who have ended their pregnancy based solely on the results of genetic prenatal screening without understanding the limitations of screening testing and the fetus may not be able to conceive. genetic abnormalities identified by screening tests”.

Recent media coverage by the Hastings Center has found that marketing around these NIPTs often includes misinformation and misinformation. The test may give false positives or false negatives. This forces the parents to terminate a normal pregnancy.

issued a similar report.

The FDA has taken this into account and has issued a statement that promotional claims about the tests, such as that they are “reliable” and “highly accurate”, may not be supported by “by sound scientific evidence”.

The result is likely to be a false positive. For example, with very rare conditions where a small segment of the chromosome is missing (microscopic, positive result) there is a greater chance of false positives than the fetus having the disease.

The agency states, “In other cases, a positive screening result may correctly detect a chromosomal abnormality, but the abnormality is present in the placenta, but not in the fetus, which may be healthy.” strong.”

The FDA also said that additional testing of genetic screening results, such as amniocentesis or chorionic villus sampling, may be needed to confirm whether the fetus does indeed have the genetic disorder. are not.

Facts about NIPT

NIPT is a screening test, not a diagnostic test, and may provide false-positive or false-negative results. Patients and their healthcare providers should understand that NIPT results may not always be conclusive and that in most cases a final diagnosis of any developing condition will be made. done after the child is born.

A false-positive result means that a common disorder is detected, but the fetus does not actually have the condition. It is called “false” because the result is wrong. False-positive results can lead to invasive testing and even surgery, which in turn leads to unnecessary worry and expense for the patient and family. However, a false test result for microproliferative syndrome is less likely than a correct one because the chances that both parents carry mutations on their respective chromosomes are very low.

The agency has also warned that no NIPT tests have been authorized or approved by the FDA. Instead, they are all classified as laboratory-developed tests (LDTs), which means their accuracy and performance are not evaluated by the FDA. The agency already has a general policy of “decision-making power” for most LDTs, which means it generally does not enforce applicable regulatory requirements for these tests.

The FDA stated in its press release that it is “continued to work with Congress on legislation to establish a modern regulatory framework for all tests, including LDT.”

“While genetic non-invasive prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and can make claims about performance and use based on good science,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Radiological Health and Devices. “Without a proper understanding of how these tests are used, people can make inappropriate health care decisions regarding their pregnancy. We strongly encourage patients to discuss this. the benefits and risks of these tests with a genetic counselor or other health care provider before making a decision based on the results of these tests.”

Josephine Johnston, director of research at the Hastings Center, says MedPage Today Note that a review of the FDA’s policy governing LDT has been underway for several years. “Tests are falling under the exemption they were never intended for, but it never changes,” she said. “There are probably strong and strong arguments for both sides of the issue.”

Source: Medindia

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