Global Down Syndrome Foundation, the National Down Syndrome Congress, and the National Down Syndrome Society Highlight the FDA’s Public Warning About Risks Associated with Non-Invasive Prenatal Screening Tests
ATLANTA, DENVER, NEW YORK (April 27, 2022) – Last week, the U.S. Food and Drug Administration (FDA) warned the public of the risk of false results, inappropriate use, and inappropriate interpretation of results with non-invasive prenatal screening tests (NIPS), also called non-invasive prenatal tests (NIPT), or cell-free DNA tests. These tests look for signs of genetic abnormalities in a fetus by testing a sample of blood from a pregnant patient.
For years, the nation’s three leading Down syndrome advocacy organizations – Global Down Syndrome Foundation (GLOBAL), the National Down Syndrome Congress (NDSC), and the National Down Syndrome Society (NDSS) – have expressed concerns over the use of, and misconceptions surrounding, these tests, due to their unregulated status. The potential for false positives, egregious mislabeling as diagnostic rather than screening tests, and the fact that some private testing companies are providing their own information about Down syndrome to pregnant women and families must be addressed.
Jeff Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, said, “While genetic non-invasive prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science.”
Together, GLOBAL, NDSC, and NDSS publish the Prenatal Testing and Information about Down Syndrome (PTP), the nation’s most widely distributed pamphlet about NIPS and Down syndrome.
An important updated version of the PTP will be released this summer to reflect the FDA’s concerns and include information about and links to the 2022 Health Supervision for Children and Adolescents with Down Syndrome published by the American Academy of Pediatrics just last week.
“We believe that it is important for parents to have, and physicians to provide, accurate, up-to-date information so that patients make decisions based on facts, not fear,” said David Tolleson, Senior Advisor Strategic Alliances at GLOBAL.
“It is very important that the public understands the limitations of these screening tests,” added Jordan Kough, Executive Director of NDSC. “In some cases, decisions are being made based on inaccurate information.”
“The FDA has warned that advertisements claiming these types of tests are ‘reliable,’ ‘highly accurate,’ and ‘offer peace of mind,’ may not be supported with sound scientific evidence,” concurred Kandi Pickard, President & CEO of NDSS. “This warning proves that, now more than ever, it is important to get accurate information – like our joint PTP – into the hands of doctors and pregnant women and families.”
Patients, healthcare providers, and the public may download the Prenatal Testing and Information about Down Syndrome pamphlet for free in English, Spanish, or Icelandic at each organization’s website. Print copies are available upon request.
Global Down Syndrome Foundation (GLOBAL)
The Global Down Syndrome Foundation is the largest non-profit in the U.S. working to save lives and dramatically improve health outcomes for people with Down syndrome.
National Down Syndrome Congress (NDSC)
The National Down Syndrome Congress is a not-for-profit organization dedicated to an improved world for individuals with Down syndrome.
National Down Syndrome Society (NDSS)
The National Down Syndrome Society is the leading human rights organization for all individuals with Down syndrome.
Anca Elena Call