deCODE forms alliance to expand outsourcing services

deCODE and Illumina have entered an agreement to develop and commercialise DNA-based diagnostics, in which deCODE will use Illumina's SNP genotyping platform to expand its contract genotyping business.

The deal also aims to use this technology to expand deCODE's analytical services that include identification of viable synthetic routes required to manufacture cGMP material in quantities for pre-clinical and clinical studies.

Under the terms of the agreement, the 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 agreement also sees both companies working on molecular diagnostics in research areas such as heart attack risk, type 2 diabetes, and breast cancer.

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

The pathways include the gene-encoding leukotriene A4 hydrolase, linked to heart attack as well as the gene-encoding transcription factor 7-like 2 (TCF7L2), linked totype 2 diabetes.

The deal will also focus on pathways involving the gene encoding BARD1, which has been linked to breast cancer.

The companies will share development costs and split the profits from sales of the diagnostics tests. No further financial details were disclosed.

Illumina's platform is designed for high-multiplex single- nucleotide polymorphism (SNP) 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.

"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."

Additional details of the agreement will see deCODE utilise the Illumina platform to carry out high-density, whole-genome studies. This will be achieved by using its population genetics resources in Iceland including more than 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 (laboratory information management system); as well as analysis and visualisation tools from Illumina's BeadStudio software.

"This 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 optimising disease prevention and treatment strategies," according to Jay Flatley, President and CEO of Illumina.

"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."