Global Down Syndrome Foundation, National Down Syndrome Congress, and National Down Syndrome Society Highlight FDA Public Warning of Risks Associated with Noninvasive Prenatal Screening Tests
Prenatal Screening and Down Syndrome Information
Atlanta, Denver, New York, April 27, 2022 (GLOBE NEWSWIRE) — Last week, the U.S. Food and Drug Administration (FDA) warned the public 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 analyzing a blood sample from a pregnant patient.
For years, the three main national Down syndrome advocacy organizations – the Global Down Syndrome Foundation (GLOBAL), the National Down Syndrome Congress (NDSC) and the National Down Syndrome Society (NDSS) – have expressed concern about the use of, and misconceptions surrounding, these tests, due to their unregulated status. The potential for false positives, blatant mislabeling of diagnostic tests rather than screening tests, and the fact that some private testing companies are providing their own information about Down syndrome to pregnant women and their families must be taken into account.
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said, “Although noninvasive genetic prenatal screening tests are widely used today, these tests have not been reviewed by the FDA and may make claims about their performance and use that are not based on sound scientific data. »
Together, GLOBAL, NDSC and NDSS publish the Prenatal Screening and Down Syndrome Information (PTP)the nation’s most distributed pamphlet on NIPS and Down syndrome.
A significant updated version of the PTP will be released this summer to reflect FDA concerns and include information and links to the 2022 Supervision of the health of children and adolescents with Down syndrome published by the American Academy of Pediatrics last week.
“We believe it’s important that parents have, and doctors provide, accurate and up-to-date information so that patients make decisions based on facts, not fear,” said David Tolleson, Advisor principal in strategic alliances at GLOBAL.
“It is very important that the public understand the limitations of these screening tests,” added Jordan Kough, executive director of the NDSC. “In some cases, decisions are made based on inaccurate information.”
“The FDA has warned that advertisements claiming these types of tests are ‘reliable,’ ‘highly accurate,’ and ‘provide peace of mind,’ may not be supported by strong scientific evidence,” confirmed Kandi Pickard, President and CEO of NDSS. “This warning proves that, now more than ever, it’s important to get accurate information – like our joint PTP – into the hands of doctors, pregnant women and families.”
Patients, healthcare providers and the public can download the Prenatal Screening and Down Syndrome Information free flyer in English, Spanish or Icelandic on each organization’s website. Printed copies are available on request.
Global Down Syndrome Foundation (GLOBAL)
the World Down Syndrome Foundation is the largest nonprofit organization in the United States 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 non-profit organization dedicated to a better world for people with Down syndrome.
National Down Syndrome Society (NDSS)
the National Down Syndrome Society is the leading human rights organization for all people with Down syndrome.
CONTACT: Anca Call Global Down Syndrome Foundation (720) 320-3832 [email protected] Rhonda Rice National Down Syndrome Congress (678) 770-6641 [email protected] Michelle Sagan National Down Syndrome Society (301) 728-0447 [email protected]