Epigenomics to Use Affymetrix Technology for IVD Tests

Epigenomics (Berlin, Germany) has announced that Affymetrix (Santa Clara, CA, USA) has granted Epigenomics non-exclusive access to Affymetrix microarray technology to develop and market microarray-based in-vitro diagnostic (IVD) tests for oncology and other indications.

The agreement complements Epigenomics' previously announced alliance with Qiagen N.V. (Venlo, The Netherlands) for sample preparation. Together with the Affymetrix arrays and DNA analysis instrumentation, Epigenomics can now provide a complete platform for its pathology tests based on its proprietary DNA methylation methods. The first products based on this platform will be pathology tests for prostate and breast cancer. Epigenomics is planning to transfer its molecular classification test (MCT) for prostate cancer onto the Affymetrix platform to use in a clinical trial for U.S. Food and Drug Administration (FDA) approval.

Under the "Powered by Affymetrix” program, companies license technology from Affymetrix to develop innovative microarray products. This includes the GeneChip System 3000Dx, a microarray instrumentation system for molecular diagnostic laboratories. This system has been cleared by the U.S. Food and Drug Administration (FDA) and has received the CE Mark in the European Union for in-vitro diagnostics use. The custom-designed technology is being used in many applications, including clinical diagnostics, forensics, animal, industrial, and food testing.

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Methylation is a natural epigenetic process that occurs when a methyl group binds to cytosine, one of DNA's four bases.

The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity that could trigger diseases such as cancer is detected. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns.

"The agreement is another important step to turn Epigenomics into an integrated diagnostics company,” said Alexander Olek, CEO of Epigenomics. "It has been our main focus over the last year to obtain gold-standard solutions for our own diagnostic products so that we can start marketing must-have diagnostic products meeting the highest industry standards. The ‘Powered by Affymetrix' program allows us to join in to the Affymetrix open platform concept, which already provides Affymetrix diagnostic partners, among them several global players, with an excellent opportunity to benefit mutually from their respective strong placement power.”

"The microarray-based tools and applications in the ‘Powered by Affymetrix' program are accelerating the discovery and development of oncology companion and predictive diagnostics in this era of molecular medicine,” said Noel Doheny, senior vice president, Molecular Diagnostics at Affymetrix. "We are pleased that another innovator in the diagnostic field like Epigenomics has adopted our proven technology platform for its in vitro diagnostic products.”



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