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They Trusted Their Prenatal Test. They Didn’t Know the Industry Is an Unregulated ‘Wild West.’
[This is not the whole article, just a few sections to emphasize the results]
In 2014, the New England Center for Investigative Reporting detailed how some companies gave a misleading impression some of the precision of the prenatal screenings. Women often didn’t understand they needed diagnostic testing to confirm the results. Some had gotten abortions based on false positive results, the story said. Earlier this year, The New York Times reported how companies sell optional extra screenings that are “usually wrong” when they predict a disorder.
“This is a Wild West scenario where everybody is on their own,” said Lawrence Gostin, a Georgetown University law professor specializing in bioethics.
The stakes for families are increasing. Upwards of half of all pregnant people now receive one of these prenatal screenings. And with many states banning abortions or limiting them to early in pregnancies, the need for fast, accurate information has become more urgent.
The FDA itself acknowledges the problem. In correspondence with ProPublica, a spokesperson cited an “outdated policy” regarding the lack of vetting of many lab tests that the agency has “spent the better part of the last two decades trying to address.”
The screening industry, meanwhile, continues to expand, proving lucrative for those who lead it. The chief executive of Natera, which claims about 40% of the market share of prenatal screenings, received a $23 million compensation package last year, the highest of any executive at a publicly traded lab company.
Today, lab-developed tests are vastly more numerous and complex. Because they aren’t registered with the federal government, nobody knows how many exist.
The distinction between tests the FDA actively regulates and those they don’t can seem nonsensical. It isn’t based on the complexity of the tests, or how people use them. It’s simply a matter of where the test is made.
The younger a person is, the lower the test’s positive predictive value — that is, the probability that a positive screening result will turn out to be correct — will be for some conditions. For instance, because Down syndrome is less prevalent in younger people’s pregnancies, a positive screening test is more likely to be a false positive for them.
via Blogger https://bit.ly/3Y4bkxn
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