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\n

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.<\/a> The agency put out a safety communication stressing that the widely used tests, often called noninvasive prenatal tests (NIPTs), aren\u2019t cleared or approved by a regulatory body. <\/p>\n
These tests often screen for rare genetic conditions in developing fetuses. But they\u2019re just screening tests, the FDA said in a statement, and a positive result does not guarantee a fetus has a genetic condition. \u201cWe 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,\u201d Jeff Shuren, director of the FDA\u2019s Center for Devices and Radiological Health, said in the statement<\/a>. <\/p>\n
All of these prenatal screening tests fall under a category called lab-developed tests, which lets companies sell medical tests without being reviewed by the FDA. They\u2019re able to advertise those tests<\/a>, and there isn\u2019t heavy scrutiny of the information included in those advertisements.<\/p>\n
A New York Times<\/em> investigation<\/a> earlier this year reported that many of these tests frequently 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 often wasn\u2019t explained to people taking those tests. Companies still say that the tests are \u201chighly accurate\u201d and can give \u201cpeace of mind,\u201d the FDA noted in its statement. \u201cThe FDA is concerned that these claims may not be supported with sound scientific evidence,\u201d the agency wrote<\/a>. <\/p>\n<\/div>\n

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Source: https:\/\/www.theverge.com\/2022\/4\/19\/23032608\/fda-prenatal-blood-tests-false-results<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"
Source: 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. 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