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newborn screening 2 articles

FDA approves first newborn screening tool for rare metabolic disorders

The Food and Drug Administration (FDA) has approved the first newborn screening tool for four rare lysosomal storage disorders (LSDs), rare inherited metabolic disorders that if not detected and treated in a timely manner can cause organ damage, neurological disability or death. The test, which will be marketed as the Seeker System, is designed to detect the LSDs Mucopolysaccharidosis Type I (MPS I) Pompe, Gaucher and Fabry. The conditions occur in about 1 in 1,500 to 1 in 185,000 newborns and children, depending on the disorder. Several states currently mandate LSD screening in all newborns, such as Arizona, Illinois, Kentucky, ... Read More

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 ... Read More