Industry News: Affymetrix Begins Shipment of Industry’s First FDA-cleared Gene Profiling Reagents

12 Jul 2011

Affymetrix, Inc. today began shipping its FDA-cleared Gene Profiling Reagents. Affymetrix also announced the availability of the new Gene Profiling Array cGMP U133 P2, a version of the widely cited Human Genome U133 Plus 2.0 Array, as another component to its GeneChip® Instrument System, which is used by Affymetrix partners for assay development.

To accelerate test development cycles, the new tools are manufactured and quality controlled under current good manufacturing practices (cGMP) and ISO 13485 standards. Additionally, with an instrument platform and reagents that are FDA-cleared for in vitro diagnostic (IVD) use and CE-marked as IVD medical devices for sale in the European Union, the Affymetrix clinical toolkit eases the regulatory burden.

Affymetrix clinical applications, along with its Powered by Affymetrix™ (PbA) partner program, are enabling major development and commercialization milestones for molecular diagnostic tests in cancer diagnostics, blood and tissue-based screening, and disease segmentation. The PbA partners are at various stages of development and commercialization of microarray-based tests; three diagnostic tests, the Roche AmpliChip® CYP450 Test, Pathwork® Tissue of Origin Test, and AMLprofiler™, are already CE-IVD or FDA-cleared, and more than ten tests are moving toward CE-IVD or nearing FDA submission.

“From a regulatory point of view, developing our standardized microarray-based AMLprofiler for diagnosing acute myeloid leukemia using Affymetrix instrumentation, reagents, and arrays is absolutely essential, and the IVD reagents are therefore a central component of the product,” said Dr. Henk Viëtor, MD, PhD, and Chief Executive Officer of Skyline Diagnostics BV, a Netherlands-based companion diagnostics pioneer and PbA partner.

Most recently, Skyline received a CE-IVD mark for its acute myeloid leukemia test and announced a research and development agreement for companion diagnostics with Janssen, a pharmaceutical division of Johnson & Johnson.
“The key element is that Affymetrix provides the tools to make it easy for us to concentrate on the content,” Dr. Viëtor emphasized. “Now, everything is fully covered, from signature discovery, to clinical application, to routine testing — a complete cycle for FDA-cleared and registered products.”

Among other recent PbA milestones is the Medicare reimbursement status achieved by Pathwork Diagnostic, Inc. for its Pathwork® Tissue of Origin Test, the first and only FDA-cleared expression-based microarray for tissue of origin for malignant tumor types. Additionally, Almac Diagnostics received Clinical Laboratory Improvement Amendment (CLIA) Certification for a new lab in France to support the company's biomarker discovery and development strategy. Also, Signature Diagnostics AG, developers of the Detector C colorectal non-invasive cancer screening test, announced a major market expansion in Germany’s IVD healthcare market.

“We are filling a growing demand for a complete gene expression solution that meets stringent U.S. and E.U. regulatory and manufacturing requirements for clinical test commercialization,” said Andy Last, PhD, Chief Commercial Officer at Affymetrix. “Our clinical toolkit and PbA partner program give clinical researchers a proven path from biomarkers to market.”
Affymetrix PbA partners, in addition to Pathwork, Almac, Signature, and Skyline, include Roche, TessArae, Ipsogen, and Veridex.