FDA Approves Test to Help Diagnose Children's Intellectual Disabilities — Physician’s First Watch
FDA Approves Test to Help Diagnose Children's Intellectual Disabilities
By the Editors
The FDA has approved the Affymetrix CytoScan Dx Assay to help detect chromosomal abnormalities in children. This information can be used to help identify causes of intellectual and developmental disabilities.
The assay analyzes a patient's entire genome using a single blood sample and can detect both large and small variations in areas of the genome linked to intellectual and developmental disabilities. In a test of 960 blood samples, the new assay outperformed karyotyping and FISH chromosomal tests in detecting abnormalities.