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FDA clears Affymetrix new gene expression reagents

The US Food and Drug Administration (FDA) has cleared Affymetrix addition of new gene expression reagents as accessories to its GeneChip Microarray Instrument System for in vitro diagnostic (IVD) use.

Affymetrix said its Gene Profiling Reagents offer convenience by simplifying assay workflow, decreasing hands-on time, and reducing quality control testing compared to research-use-only (RUO)-produced products.

Central to the Affymetrix expression platform is the Gene Profiling Array, the cGMP-manufactured version of the widely cited GeneChip Human Genome U133 Plus 2.0 Array, along with the custom signature arrays built from the HG-U133 Plus 2.0 Array.

The Affymetrix gene expression instrument platform has been developed and commercialized through its PbA partners, and is already in use with two FDA-cleared tests, the Roche AmpliChip CYP450 Test and Pathwork Diagnostics’ Tissue of Origin Test.

Skyline Diagnostics BV also uses the platform to develop its AMLprofiler molecular diagnostic assay, which is CE marked for IVD use in the EU and will be submitted to the FDA.

Affymetrix president and CEO Kevin King said thousands of research customers and powered by Affymetrix (PbA) partners use their research products every day to identify signatures or expression patterns that may lead to a cancer diagnostic or an improved therapy determination for patients.