Blood tests that screen pregnant people for signs of genetic abnormalities run the risk of giving people false or misleading information, the Food and Drug Administration warned Tuesday. The agency released a safety statement highlighting that the commonly used tests, often referred to as non-invasive prenatal tests (NIPTs), have not been approved or approved by any regulatory agency.
These tests often screen for rare genetic disorders in developing fetuses. But they’re just screening tests, the FDA said in a statement, and a positive result doesn’t guarantee a fetus has a genetic condition. “We urge patients to discuss the benefits and risks of these tests with a genetic counselor or other health care provider before making decisions based on the results of these tests,” said Jeff Shuren, director of the Center for Devices and The FDA’s Radiological Health, said in the statement†
All of these prenatal screening tests fall under a category called lab-developed tests, which allow companies to sell medical tests without being reviewed by the FDA. They may promote those tests and the information in those ads is not strictly controlled.
A New York Times research earlier this year reported that many of these tests often have false-positive results for rare conditions. Positive results were wrong 80 percent of the time or more for things like Cri-du-chat syndrome. Because the condition is so rare, incorrect results are common, but that was often not explained to people taking those tests. Companies still say the tests are “highly accurate” and can provide “peace of mind,” the FDA said in its statement. “The FDA is concerned that these claims may not be supported by sound scientific evidence,” the agency said wrote†
SOURCE – www.theverge.com