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Epigenomics and Affymetrix Announce Strategic Diagnostics Platform Agreement
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Epigenomics AG and Affymetrix Inc. have announced that Affymetrix 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 strategic alliance with Qiagen N.V. 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 in prostate and breast cancer.
As the first example, Epigenomics is planning to transfer its Molecular Classification Test (MCT) for prostate cancer onto the Affymetrix platform to use it in the pivotal clinical trial for FDA approval of the assay, which is scheduled to start next year.
"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."
"Last year, we closed a strategic alliance with Qiagen to develop a cutting-edge solution portfolio for sample preparation," Olek added.
"While the Qiagen alliance will provide us with robust, reliable, and easy-to-use kits for the preparation of clinical samples to enable the actual DNA methylation test, the agreement with Affymetrix now adds the industry standard for DNA analysis."
"As a result, our customers will get the world's leading technologies for rapid and reliable DNA methylation analysis."
"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."
Under the Powered by Affymetrix program, companies license technology from Affymetrix to develop microarray products.
This includes the GeneChip® System 3000Dx (GCS3000Dx), the microarray instrumentation system for molecular diagnostic laboratories.
The GCS3000Dx has been granted regulatory clearance by the U.S. Food and Drug Administration and is CE marked in the European Union for in-vitro diagnostic use.
The custom-designed technology is being used in many applications, including clinical diagnostics, forensics, animal, industrial, and food testing.
