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FDA OKs Blood Test For Intellectual Disability

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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.

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.

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Comments (2 Responses)

  1. Michael Wehemeyr says:

    I appreciate the excellent disability focus that Disability Scoop provides. In this case, however, I believe the headline you’ve used is misleading and, if picked up by mainstream media, potentially problemmatic. You can’t do blood tests for “intellectual disability.” Intellectual disability is a state of functioning that is diagnosed by significantly subaverage intellectual functioning and in adaptive behavior occurring in the developmental period. This blood test detects chromosomal variations associated with medical conditions that, in turn, are often (but not always) associated with manifesting intellectual disability. Identifying it as a test for intellectual disability concerns me, though in fairness, the scientist who is quoted does not do that: “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. Dr. Gutierrez rightfully classifies this as a test for possible causes of developmental delay or intellectual disability and positions it as a tool to assist health care providers and parents to intervene with appropriate care and support… which it certainly might be, perhaps, for example, ensuring earlier entry into early childhood. That said, any tool can be a weapon… some of us who have written about the history of intellectual disability can see such a test used in less positive ways.

    While I’m at it… one does not have “some form of intellectual disability.” One meets the diagnostic criteria for intellectual disability or not. I do applaud, though, your use of the singular “intellectual disability.” Too often people write “intellectual disabilities,” which is incorrect, as there are not multiple forms of intellectual disability (we never used the plural of the now outdated term “mental retardation”–i.e. mental retardations).. There are differing levels of impairment associated with intellectual disability, but not multiple forms.

  2. Jennifer says:

    Thank you Michael for pointing this out. They should have changed the title already. My son has a syndrome that can cause an intellectual disability, but the syndrome is not an intellectual disability. There is an important distinction.

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