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Affymetrix Inc receives FDA Clearance of First-of-its-kind postnatal test for developmental delays and intellectual disabilities in children

Tuesday, 21 Jan 2014 06:00am EST 

Affymetrix Inc:Says it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its CytoScan Dx Assay.Says this assay is intended for the postnatal detection of DNA copy number variants (CNV) in patients referred for chromosomal testing.Says CytoScan Dx Assay is designed to help physicians diagnose children`s developmental and intellectual disabilities more comprehensively by enabling a high-resolution genome-wide analysis of genetic aberrations.Says high resolution analysis can reveal small aberrations not readily seen using traditional techniques. 

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27 Nov 2015