Affymetrix Receives FDA Clearance to Market CytoScan Dx Assay

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Affymetrix
AFFX
today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its CytoScan® Dx Assay. This assay is intended for the postnatal detection of DNA copy number variants (CNV) in patients referred for chromosomal testing. 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. High resolution analysis can reveal small aberrations not readily seen using traditional techniques.
See full press release
Posted In: NewsGuidanceFDAManagementGlobal
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