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Regulation Needed

As they become better developed and more widespread, non-invasive prenatal genetic tests may get caught up in the furor over abortion in the US and, to a lesser extent, in Europe, writes the University of California Hastings College of the Law's Jaime King in Nature. She argues that the US Food and Drug Administration needs to develop a regulatory framework for such tests and help educate the public about the tests and what they can determine.

"NIPT has the potential to improve women's reproductive autonomy. But if it is not integrated cautiously into prenatal care, the technology could be targeted to support burgeoning strategies to restrict abortion," King writes. She notes that a bill to ban abortions based on the gender or genetic abnormalities has been introduced in Missouri.

FDA, she says, needs to develop a regulatory framework that states what accuracy and what clinical utility non-invasive prenatal genetic tests need to have for them to be marketed. Then, in conjunction with professional societies and patient advocacy groups, King adds that FDA should develop a way to educate the public about these tests, when they are ready for widespread use.

"Once we're capable of ... making it commercially available, at that point, the real fear is that parents will get inundated with a flood of information about their fetus and not really understand what the full range of implications are," King tells LiveScience.

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