FDA OKs Blood Test For Intellectual Disability
A first-of-its-kind blood test that can help diagnose intellectual disabilities and developmental delays in children is getting the go-ahead from the Food and Drug Administration.
The test known as CytoScan Dx Assay analyzes the entire genome and can detect chromosomal variations associated with Down syndrome, DiGeorge syndrome and other intellectual and developmental disabilities, the FDA said.
“This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.
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The test made by Affymetrix is not for prenatal use and should be used by doctors in conjunction with other diagnostic and clinical findings, officials said.
Two to three precent of U.S. children have some form of intellectual disability, according to the National Institutes of Health and the American Academy of Pediatrics.