FDA Oversight Needed

New York — In the last decade many women have come to rely on Noninvasive Prenatal Tests (NIPTs) as a normal part of the pregnancy process to determine the health and viability of the fetus they are carrying. An explosive new investigation by the New York Times, and subsequent reporting, has revealed that this unregulated testing industry is dangerously misleading.

“We are deeply concerned that women are making life-changing decisions with unreliable and inadequate information based on these unregulated tests,” said Sonia Ossorio, Executive Director of Women’s Justice NOW. “Expectant parents deserve to be given all the facts that they need as they embark on these tests.”

NIPTs are blood screening tests that examine the fetus’ DNA to determine whether the fetus is at risk for development disorders or conditions. The key word here is screening—the tests are screening tests, not diagnostic tests. Far too often this is not explained to patients and testing companies often make misleading claims promising high levels of ‘accuracy’ and ‘reliability’ for their tests.

This point is made all the more salient by the fact that screening tests produce false positive results 80 percent of the time or more as reported by the NYT. For one condition, studies found its positive results were false more than 90 percent of the time.

In the past, most NIPTs were for Down syndrome and other common developmental problems. As testing became more popular, the industry quickly expanded and companies, from large well established ones to start ups, got into the business of promoting new tests for rarer conditions. Today, the competitive global prenatal testing market is estimated to exceed $4.5 billion by 2024.

It is also apparent that many patients do not receive any kind of pre- or post-testing counseling where they can ask questions and be informed about testing limitations and the need for follow-up testing.

As a result, and as was highlighted in the NYT investigation, some expectant parents are left to believe that a positive result on a screening test is akin to a diagnosis. They are faced with confusion and unnecessary anguish. In some cases, women have terminated their pregnancies without taking further tests to confirm the original result.

Because the FDA does not regulate prenatal testing, companies are not required to publish data on their tests’ overall performance, and their marketing claims do not need to be supported by evidence.

“We call on the FDA to act immediately to ensure appropriate oversight of Noninvasive Prenatal Testing, and on elected officials to hold this unregulated industry accountable for misleading the public,” Ossorio said.

Women’s Justice NOW is building a future of social justice and equality for all women by mobilizing communities, developing new activist leadership, and providing direct help and advocacy to women.

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What you should know about prenatal testing:

• Noninvasive Prenatal Tests are not regulated by the FDA.
• Prenatal tests are screening tests, not diagnostic tests, meaning a positive result indicates a risk of a genetic condition, it is not a diagnosis.
• It is recognized that some patients will have false positive results. As the New York Times reported, some screening tests produce false positive results 80% of the time or more. However, the tests are highly accurate in screening for Down syndrome.
• Follow-up diagnostic tests are needed to determine true positive results. These diagnostic tests can be invasive, expensive, and associated with some risks.
• Pretest counseling is crucial. Practitioners must educate patients about limitations before testing.
• Patients must receive accurate information and counselling both before and after any kind of prenatal testing.
• Be wary of marketing materials from prenatal testing companies claiming high accuracy and reliability. Their claims do not need to be supported by evidence.
• Current guidelines, including those from the American College of Medical Genetics and Genomics and the American College of Obstetricians and Gynecologists, recommend noninvasive prenatal screening for common disorders, but not for less common syndromes caused by microdeletions, or missing pieces of chromosomes.