Affymetrix Inc. (AFFX) Receives FDA Clearance for Gene Expression Technology
Affymetrix Inc. yesterday announced it has received U.S. Food and Drug Administration clearance for the addition of new gene expression reagents as accessories to the company’s GeneChip® Microarray Instrument System for in vitro diagnostic (IVD) use, positioning Affymetrix as the first company in the industry to provide a comprehensive microarray-based clinical toolkit for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives. The Affymetrix gene expression platform is a comprehensive system used for enabling the development of clinical diagnostic tests. The company said the technology was designed to reduce development time by easing the regulatory burden and delivering…