FDA Approves Genetic Tests To Determine Symptoms Of Intellectual Disabilities In Infants

The food and Drug Administrationx(FDA) flagged off the genetic test on Friday, used to determine intellectual disabilities or developmental delays in children.

The test initiated by Santa Clara-based lab Affymetrix, detects even alterations in chromosomes related to Down syndrome, DiGeorge syndrome and other developmental disorders. The test called CytoScan Dx Assay, utilizes high-powered computer, scanning a gene chip of the patient's DNA and tracks the irregularities in the chromosomes, reports ABC news.

According to FDA guidelines, the test is safe on infants and produce accurate results. However, FDA has cautioned for not to use the test for each and every newborn. Rather the test will act as an additional tool for the the doctors to confirm intellectual disabilities in kids.

"This test is going to provide an additional diagnostic tool for treatment of children with identified developmental problems and disabilities," said Dr. Annemarie Stroustrup, an assistant professor of pediatrics and newborn medicine at Mount Sinai Hospital in New York City, reports Philly.

The parents should not use this test as an early predictor to detect the future mental ability of their children rather should wait for their children to show some symptoms of developmental delay and then to go for the test to confirm the same, Stroustrup stated. 

In U.S. two- three percent of kids are found with some sort of intellectual disabilities and many of these problems are related to Down syndrome and DiGeorge syndrome, reveals a recent report by U.S. National Institutes of Health. An effective screening tool will help in faster diagnosis of these symptoms and to provide required treatments on time according to pediatrics.

There were also other generic tests to determine the changes in chromosomes related to Down syndrome but those are time consuming and expensive. But CytoScan Dx Assay takes less time and more comprehensive in approach is more apt to detect the developmental delays, the health experts said.