FDA Okays Blood Test that Detects Chromosomal Changes Linked with Intellectual Disabilities in Children

A novel blood test that detects intellectual disabilities in babies has now gotten a nod from The Food and Drug Administration.

In an announcement made Friday, the agency said that it has authorized marketing of the Affymetrix CytoScan Dx Assay. The test uses a blood sample from the child to analyze his/her genome and detect chromosomal changes that could be associated with mental difficulties.

Certain intellectual disabilities such as Down syndrome and DiGeorge syndrome are linked with chromosomal variations.  According to the National Institutes of Health and the American Academy of Pediatrics, about two to three percent of all American children have some kind of developmental delays.

The newly approved assay is manufactured by Affymetrix, Inc., located in Santa Clara, Calif.

"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, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "The FDA's review of the test provides clinical laboratories with information about the expected performance of the device and the quality of the results."

The test is for post-natal detection of mental problems and not for pre-natal screening or predicting genetic mutation associated with cancers, Associated Press reported.

The agency said that it approved the test after studies showed that it accurately analyzed patients' genome and looked for variations associated with intellectual disabilities.