Office of the Food and Drug Administration (FDA) first issued in the US market postnatal test, allowing for a blood test to identify the newborn child in a genetic propensity for developmental delay and mental retardation, according to a press release from the agency.
According to the National Institutes of Health (NIH) and the American Academy of Pediatrics (AAP), various forms of the backlog in intellectual development occur in 2-3 percent of American children. The basis of most of these disorders are chromosomal abnormalities.
Designed by Californian company Affymetrix test CytoScan Dx Assay allows a drop of blood to conduct genome-wide analysis of the infant and to identify chromosomal variations of different types, sizes and locations in specific regions of the genome associated with impaired intellectual development. The test is not intended for prenatal screening or detection of predisposition to other genetically determined condition or disease.
Testing the effectiveness CytoScan Dx Assay for example, 960 blood samples showed its superiority over other methods applied to identify chromosomal abnormalities, such as karyotyping and fluorescent hybridization (FISH-test).
As the representative of the FDA Alberto Gutierrez (Alberto Gutierrez), the introduction of a new method in clinical practice to help identify possible causes of early developmental delay, allowing doctors and parents at an early stage to provide children with the necessary assistance and support.
In hospitals all 50 US states last half-century has a national screening program for all newborns genetically determined diseases available to identify blood test, including sickle cell anemia and cystic fibrosis (cystic fibrosis). To date, screening covers 29 such diseases. Will testing using CytoScan Dx Assay included in the national newborn screening program, not reported.