Market Overview

Affymetrix Receives FDA Clearance to Market CytoScan Dx Assay

Affymetrix (NASDAQ: 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: News Guidance FDA Management Global

 

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