Attention, parents: The FDA has signed-off on the first-of-its-kind blood test that will help diagnose mental disabilities in babies. The test, which analyzes a baby’s genetic code, is known as the CytoScan Dx Assay, and has been designed to detect disabilities earlier than any other test available. It’s not intended for prenatal screening or for predicting other genetically acquired diseases and conditions (such as cancer), but it will give parents a clearer understanding of their newborn’s mental future.
According to a report from the National Institutes of Health, about two to three percent of US children are born with some type of intellectual disability. CytoScan Dx Assay will help detect variations in patients’ chromosomes that may be liked to DiGeorge syndrome and Down syndrome as well as developmental disorders. On Friday, when the formal FDA statement was released, pediatricians said that the test (developed in a Affymetrix laboratory) will provide a faster, more comprehensive screening approach. The tests, however, are generally only used after children exhibit some type of physical or behavioral signs that suggest a disorder.
Dr. Annemarie Stroustrup, assistant professor of pediatrics at Mount Sinai Hospital in New York, told ABCNews.com, “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. This is not a screening test to be done on all newborns to predict how they are going to do in school when they are 5.”
So what makes CytoScan so promising? The technology used to develop the test has already been in place for several years — and has been used to screen fetuses for potentially debilitating diseases. The FDA said that they had chosen to approve the new test based on studies that revealed how accurately CytoScan had analyzed a patient’s entire genomes, which revealed spot variations associated with intellectual debilitates. The analysis, known as microarray analysis, involves a high-powered computer that scans a gene chip of a patient’s DNA for chromosomal imbalances. In the past, the only available technique was to analyze genes and chromosomes individually, under a microscope.
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