FDA clears CytoScan Dx, 3/14

March 2014—Affymetrix received FDA 510(k) clearance to market its CytoScan Dx assay, intended for the postnatal detection of DNA copy number variants in patients referred for chromosomal testing. Cyto­Scan Dx is designed to help diagnose children’s developmental and intellectual disabilities more comprehensively by enabling a high-resolution, genome-wide analysis of genetic aberrations.

Affymetrix, 408-731-5523