In 2014, the New England Center for Investigative Reporting detailed how some companies gave a misleading impression 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.
Despite these stories and calls for reform by patient advocates, the government has done little to improve oversight of prenatal screenings.
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 In correspondence with ProPublica, a spokesperson cited an “outdated policy” regarding the lack of vetting of many lab tests that the agency has “spent the better part of the last two decades trying to address.”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.
