Scan tracks entire genome from a blood sample
FRIDAY, Jan. 17, 2014 (HealthDay News) -- A new test to diagnose developmental delays and intellectual disability in children based on genetic abnormalities has been approved by the U.S. Food and Drug Administration.
The Affymetrix CytoScan DX Assay scans the entire genome from a blood sample and detects chromosomal variations that can lead to developmental and learning problems in children, the agency said Friday in a news release.
Intellectual disability affects as many as 3 percent of children in the United States, the agency said.
Analysis of 960 blood specimens found the new test was better at detecting chromosomal abnormalities that could lead to intellectual disability than other standard tests, the FDA said.
The new test is produced by Affymetrix Inc., based in Santa Clara, Calif.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382179.htm )