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Illumina and deCODE Form Alliance to Develop and Commercialize DNA-Based Diagnostics

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Illumina, Inc. and deCODE genetics have announced the formation of a strategic alliance under which the companies plan to co-develop and commercialize DNA-based diagnostic tests in several major disease areas.

The alliance will employ Illumina's platform for high-multiplex single-nucleotide polymorphism genotyping to develop tests for gene variants deCODE has previously shown to have impact on the risk of a growing number of common diseases with major public health impact.

Under the terms of the agreement, Illumina will gain access to disease-related biomarkers for joint validation as diagnostic panels to be marketed and sold by Illumina on its forthcoming BeadXpress platform.

The companies will share development costs and split the profits from sales of the diagnostics tests.

The alliance will initially focus on the development, validation and commercialization of specific diagnostic tests for variants in genes involved in three disease-related pathways:

- the gene-encoding leukotriene A4 hydrolase, linked to heart attack;

-  the gene-encoding transcription factor 7-like 2 (TCF7L2), linked to type 2 diabetes;

-  the gene encoding BARD1, linked to breast cancer.

As part of the agreement, Illumina will install its SNP genotyping platform at deCODE, enabling deCODE to expand its contract genotyping business to offer Illumina platform and assay technologies together with deCODE's proprietary analytical services for customers.

deCODE will utilize the Illumina platform to carry-out high-density, whole-genome studies utilizing its comprehensive population genetics resources in Iceland including 100,000 participants in some 50 common diseases.

This effort, which will enhance deCODE's proprietary gene and drug target discovery work and may provide genetic markers for additional diagnostic development, will leverage Illumina's Sentrix® HumanHap BeadChips; Infinium™ assay and LIMS; as well as analysis and visualization tools from Illumina's BeadStudio software.

"This alliance enables us to strengthen our global leadership in using human genetics to discover and develop better medicine - accelerating our target discovery work and enabling us to generate near-term product revenue from the development of diagnostics," said Kari Stefansson, CEO of deCODE.

"Our recent discoveries have demonstrated the power of applying high-density SNP genotyping to our population resources."

"We are very impressed with the quality of Illumina's SNP platform and look forward to working with such an agile and effective partner to bring to market a new generation of DNA-based diagnostics."

According to Jay Flatley, President and CEO of Illumina, "This landmark agreement will aid in the discovery of powerful biomarkers associating genetics and disease and the application of these discoveries to develop new products."

"We expect the tests developed by the alliance to provide novel means of predicting disease risk and of optimizing disease prevention and treatment strategies."

"deCODE has pioneered the use of population genetics to better understand and improve both individual outcomes and human health in general."

"We're excited to join forces with a company that has demonstrated scientific leadership using gene discovery to address the therapeutic challenges of complex human diseases."