Affymetrix Achieves First FDA Clearance of Microarray-Based Gene Profiling Reagents (AFFX)

Affymetrix, Inc. AFFX today announced that the U.S. Food and Drug Administration has cleared the addition of new gene expression reagents as accessories to its GeneChip Microarray Instrument System for in vitro diagnostic use, making Affymetrix the first in the industry to provide a comprehensive microarray-based clinical toolkit for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives. Affymetrix Gene Profiling Reagents offer unparalleled convenience by simplifying assay workflow, decreasing hands-on time, and reducing quality control testing compared to research-use-only-produced products. Use of the Gene Profiling Reagents for clinical diagnostic test development should lead to more consistent results and lower commercialization costs for clinical providers and other Affymetrix customers.