FDA OKs Mental Disability Blood Test for Infants
The Food and Drug Administration has cleared a first-of-a-kind blood test that can help predict intellectual disabilities in infants by analyzing their genetic code.
The laboratory test from Affymetrix detects variations in patients' chromosomes that are linked to Down syndrome, DiGeorge syndrome and other developmental disorders. About 2 to 3 percent of U.S. children have some sort of intellectual disability, according to the National Institutes of Health.
The test, known as the CytoScan Dx Assay, is designed to help doctors diagnose children's disabilities earlier and get them appropriate care and support. It is not intended for prenatal screening or for predicting other genetically acquired diseases and conditions, such as cancer.
Affymetrix Inc. is based in Santa Clara, Calif.