FDA Clears Affymetrix Gene Expression Reagents for IVD Use | GenomeWeb

Affymetrix this week said that the US Food and Drug Administration has cleared its Gene Profiling Reagents as accessories to its GeneChip microarray instrument system for in vitro diagnostic use.

The Santa Clara, Calif.-based life science tools vendor now claims to be the "first in the industry" to offer array-based tools for diagnostic test development, signature discovery for companion diagnostics, and translational initiatives.

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