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

Affymetrix, Inc. 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 (IVD) 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 (RUO)-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.

With a full complement of arrays, assays, a data processing solution, an instrument system, and reagents manufactured under current Good Manufacturing Processes (cGMP) and ISO 13485 standards, the Affymetrix gene expression platform is the most comprehensive and reliable system available for enabling the development of clinical diagnostic tests. This industry-leading system’s high standards aim to shorten development time by easing the regulatory burden and delivering reproducible results.

“Affymetrix created the technology and marketplace for multiplexed gene expression more than a decade ago, and this clearance of our gene profiling reagent kit by the FDA marks another milestone in our leadership in this important market segment,” said Kevin King, President and Chief Executive Officer of Affymetrix. “Thousands of research customers and Powered by Affymetrix™ (PbA) Partners use our research products every day to identify signatures or expression patterns that may lead to a cancer diagnostic or an improved therapy determination for patients. These customers can now seamlessly migrate from basic signature discovery to validation on a robust system.”

The Affymetrix gene expression instrument platform has a well-established record of successful development and commercialization 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 B.V. also used 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. Additional tests are in the pipeline.

“Customers who are commercializing products on the Affymetrix clinical platform can rely on our proven technology, global distribution, services, and support organization,” said Affymetrix Chief Commercial Officer Andy Last. “Affymetrix is leading the industry into the era of personalized medicine by turning our knowledge about biology, genes, and disease into tangible clinical applications, and ultimately, into diagnostic decisions that improve quality of life.”

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 Gene Profiling Array is scientifically validated by more than 3,000 clinical publications, and users will have access to the largest gene expression research database available for signature development.