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Caution Urged

The US Food and Drug Administration cautions that non-invasive prenatal genetic tests are screening, rather than diagnostic, tests and could give false results, as GenomeWeb reports.

In a press release, the FDA notes that all NIPTs currently in use are lab-developed tests and though many are advertised as "reliable" and "highly accurate," it is concerned that those claims might not be supported by evidence. Further, it says that because some of the conditions the tests screen for are quite rare, positive results are more likely be a false, rather than a true, positive.

The agency notes that it was moved to issue its statement due to increased use of NIPTs and recent media reports. Earlier this year, as the Verge notes, the New York Times reported that NIPT results were often wrong. Further, it was not always clear to patients that the tests were screening tests that may need additional confirmation.

In its statement, the FDA urges patients and healthcare providers to be aware of the limitations of NIPTs. "We strongly urge patients to discuss the benefits and risks of these tests with a genetic counselor or other healthcare provider prior to making decisions based on the results of these tests," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, says in a statement.

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