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.
In the face of the Supreme Court overturning Roe v. Wade, Congress must act to hold this industry accountable. NOW-NYC demands that our elected leaders make women’s health and lives a priority. We need hearings and action, not just campaign messaging and political posturing.
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.
Get the facts.
- 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.
Take action.
Speak to our elected officials and demand that they take women’s reproductive health seriously, not just as a talking point. Here’s what you can say:
“I am urging [Senator ____ ] to 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. Right now, screening tests produce false positive results 80 percent of the time or more as reported by the New York Times. 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. The FDA must require companies to publish data on their tests’ overall performance, and support their marketing claims with evidence.”
To start, you could call Senate Majority Leader Chuck Schumer at (212) 486-4430.
NOW is here for you. raise your voice and take action.