The U.S. Food and Drug Administration (FDA) today approved a new test designed to detect developmental delays and intellectual disabilities in children. The test is marketed by Affymetrix under the name CytoScan Dx Assay and can detect disabilities such as Down syndrome.
The test works by quickly analyzing a child's genome, allowing it to detect chromosomal changes. The process specifically targets areas of the hman genome known to be associated with intellectual and developmental disabilities.
The test is designed to allow health professionals to diagnose intellectual and developmental disabilities early in a child's life, giving parents and doctors more time for interventions or to prepare for the consequences of such disabilities.
The CytoScan Dx Assay test was approved under the FDA's de novo classification, which provides a quick regulatory process for "novel low-moderate-risk medical devices." The FDA determined through the process that the test adequately detects chromosomal variations based on size, type, and position. Another test reviewed by the FDA found that the CytoScan Dx Assay is better at detecting certain chromosomal variations than tests that are currently in common use.
“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 In Vitro Diagnostics and Radiological Health at the FDA. “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.”