Republican politicians are calling for accountability after an analysis claiming certain prenatal testing products yielded high numbers of false positives for genetic disorders, raising questions about how many mothers requested abortions because of inaccurate diagnoses.
The recent New York Times report created a frenzy on social media as it claimed that positive results from common prenatal tests resulted in false positives 85% of the time. Implications of false positives could be widespread. According to the report, a company known as Natera said it performed 400,000 screenings for one microdeletion in 2020.
“Faulty pre-natal testing places women in agonizingly painful situations,” Sen. Ben Sasse, R-Neb., said in a statement to Fox News Wednesday. “These companies claim these tests are trustworthy but clearly they’ve got big problems, and the FDA should investigate how so many moms and babies were hurt by such shoddy testing.”
Sen. Ben Sasse, R-Neb., on April 27, 2021 in Washington, D.C. (Tasos Katopodis-Pool/Getty Images)
Sen. Josh Hawley, R-Mo., called on the companies involved to immediately stop selling their testing products.
“It’s no surprise that these tests are coming from Silicon Valley, which is the epicenter in this country of things that harm families,” he said.
“People are getting abortions based on these false tests. These companies are responsible for countless deaths, countless missing brothers or sisters. They must immediately stop selling these tests, and they must be held accountable.”
Sen. Josh Hawley, a Republican from Missouri, speaks during a Senate Judiciary Committee hearing in Washington, D.C.
(Graeme Jennings/Washington Examiner/Bloomberg)
Natera, one of the biotech companies in the report, claims that its test was accurate in more than 99% of cases.
“[O]ur test is accurate in > 99% of cases. For example, in the SMART study, the largest prospective NIPT study ever conducted, we reported clinical results for 22q11.2 (22q) deletion syndrome to 18,014 patients, and we delivered a correct result to 17,982 of those patients (99.8%),” a Monday press release reads.
Natera adds that they recommend further testing and genetic counseling. “We also believe all patients should have access to genetic counseling resources during their pregnancies – and Natera provides complimentary genetic information sessions so patients can speak directly to board-certified genetic counselors before or after their testing,” the company said.
“While we’ve made significant effort to ensure we provide appropriate educational material and we believe we are transparent with our performance, we are committed to doing more to help educate patients.”
Kristi Noem, governor of South Dakota, speaks during the FAMiLY Leader summit in Des Moines, Iowa, U.S., on Friday, July 16, 2021. (Rachel Mummey/Bloomberg via Getty Images)
The Times said its analysis drew on peer-reviewed studies as well as interviews to evaluate tests for disorders like Cri-du-chat syndrome and DIGeorge syndrome.
The controversy came at an especially critical time in the abortion debate as the Supreme Court heard potentially game-changing cases on the issue. Several states and the U.S. Congress have also considered provisions surrounding abortions that target fetuses with genetic abnormalities.
South Dakota Gov. Kristi Noem, who previously pushed a Down Syndrome abortion ban in her state, told Fox News: “These companies should be held accountable for the lives that have been lost because of the faulty information they gave to parents.”
The report could prompt further additional inquiries as Natera’s work has received support from the National Institutes of Health (NIH).
Both Natera and Sequenom, which was acquired by LabCorp, have worked with StemExpress – the tissue procurement company caught up in a congressional investigation surrounding Planned Parenthood’s fetal tissue practices. The company has denied wrongdoing and while a 2015 select panel resulted in federal referrals, it’s unclear how those have proceeded through the executive branch.
Sam Dorman is a reporter with Fox News. Follow him on Twitter @DormanInDC or at facebook.com/SamDormanFoxNews