Pharmaceutical

FDA approves first newborn screening test for intellectual disabilities

sleeping baby 435x310 FDA approves first newborn screening test for intellectual disabilities Federal drug regulators have granted approval for a first-of-its-kind blood test that can detect intellectual disabilities in infants by scanning variations in patients’ chromosomes that are linked to many developmental disorders.

The laboratory test, known as CytoScan Dx Assay is made by medical technology company Affymetrix. It is the first FDA-approved test that analyzes the whole genome in a single procedure at very high resolutions.

An intellectual disorder is a condition in which a person has limitations in mental functioning and skills such as communicating, taking care of him- or herself, and social skills. These limitations will cause a child to learn and develop more slowly than a typical child.

An estimated two to three percent of children born in the United States have an intellectual disability. Early diagnosis and intervention is key to helping these children reach their full potential.

The CytoScan Dx Assay test is designed to help diagnose these disabilities in children and infants. It is not intended for prenatal screening or predicting other genetically acquired diseases and conditions.

Currently, hospitals are required to screen newborns for at least 29 disorders that can be detected through laboratory testing. These tests, which began more than five decades ago, detect conditions such as sickle cell anemia and cystic fibrosis.

The FDA approved the test based on studies that showed it accurately analyzed patients’ entire genome and could accurately detect variations associated with intellectual disabilities.

Source: PharmPro