News Feature | January 30, 2014

FDA Approves Blood Test To Screen For Mental Disorders In Newborns

Source: Clinical Leader

By Cassandra Leger

The U.S. FDA announced that the administration had approved a blood test that can be administered on babies, in order to identify and diagnose mental disabilities. The identification process occurs after a matching gene associated with mental disabilities is found in the baby’s genetic code. This is the first blood test of it’s kind to gain approval by the FDA.

The test, called CytoScan DX, by Affymetrix identifies certain variations in the patient’s  chromosomes that are known to be associated with mental disorders -  particularly Down Syndrome and DiGeorge Syndrome. According to statistics provided by the National Institute of Health, 1% - 3% of children in the U.S. have one of many different mental disorders, conditions or disabilities. The test only works to detect mental disorders and not other genetically predisposed conditions. The test  is not for prenatal use.

Currently there are tests available to health care professionals for the detection of mental disorders such as Down Syndrome, however, these must be ordered on an individual basis and take a while to provide results making the process more expensive and elongated. This new CytoScan DX test offers pediatricians a quicker, more comprehensive screening process. While this is an early-screening test, it is not meant for use on every newborn; it will still only be administered to children who show signs of unusual behavior. Dr. Annemarie Stroustrup, Assistant Professor of Pediatrics, Mount Sinai Hospital, New York, stated "When there's something about the child that strikes us as unusual or pointing to a potential genetic disease, that's when we would use this testing." She went on to say, "his is not a screening test to be done on all newborns to predict how they are going to do in school when they are five."

The technology used in the CytoScan test has been in use for a number of years by doctors to screen fetuses in order to detect debilitating diseases. Currently all 50 stated in the U.S. are required by law to screen newborns for 29 disorders. The majority of these screening metabolic in nature and not genetic like the CytoScan test.

Source:

http://www.timesheraldonline.com/business/ci_24962794/fda-oks-mental-disability-blood-test-infants