Illumina and DeCode Genetics this week announced that they plan to co-develop and commercialize DNA-based diagnostics in several major disease areas.
According to the firms, the partnership will use Illumina's platform for high-multiplex SNP-genotyping to develop diagnostics for gene variants that DeCode has shown to be risk factors for developing diseases such as type II diabetes, myocardial infarction, and breast cancer.
For Illumina, the deal underscores its belief that biopharmas will be adopting its whole-genome genotyping technology for internal drug discovery in greater numbers, and could become a blueprint for other diagnostic alliances.
Terms of the deal call for Illumina to install a customized suite of its SNP-genotyping BeadStations at DeCode's labs in Iceland, which will use the platform for internal drug discovery. In exchange, Illumina will gain access to disease-related biomarkers identified by DeCode that both shops plan to validate as diagnostic panels.
The partners said that they will focus on the gene encoding leukotriene A4 hydrolase, which has been linked to heart attack; the gene encoding transcription factor 7-like 2, which is linked to type II diabetes; and the gene encoding BARD1, which is linked to breast cancer.
The companies also said they will share development costs and split the profits from sales of the diagnostics.
Illumina will market and sell these panels to clinical labs on its forthcoming BeadXpress platform, which is currently scheduled to launch at the end of the fourth quarter (see BAN 4/26/2005).
Until now, Illumina has said only that it will offer its Golden Gate genotyping assay on the BeadXpress system, although it has openly discussed its intent to use BeadXpress as a springboard into the molecular diagnostics market. Illumina acquired BeadXpress, a non-array-based platform that uses the glass particle microbead technology, from CyVera in April 2005.
While the DeCode agreement has shed light on the kinds of tests customers can expect to see in the future, Illumina spokesperson Bill Craumer hesitated to say that the deal illustrates the way Illumina plans to develop tests from here on out, and said the company would explore other means of adding to the BeadXpress menu in the future.
"Our company's diagnostics model is undefined," Craumer said. "Clearly we want to leverage our BeadXpress platform."
Craumer also said that the deal was significant for Illumina beyond the likelihood of future diagnostics. According to the deal, DeCode plans use Illumina's BeadStation to perform whole-genome studies on more than 100,000 participants in Iceland for some 50 common diseases.
The companies said the effort will "enhance DeCode's proprietary gene and drug-target discovery work and may provide genetic markers for additional diagnostic development."
Craumer said that the hardware for the studies should be installed in DeCode's Reykjavik facility by the third quarter. He added that DeCode is "familiar" with the system but declined to say to what extent. DeCode could not be reached for comment.
In a statement, DeCode CEO Kari Stefansson said the alliance will accelerate the company's target-discovery work, while the diagnostics expected from the alliance will generate near-term product revenue.
"Our recent discoveries have demonstrated the power of applying high-density SNP genotyping to our population resources, Stefansson said.
In the past, DeCode has also worked with Illumina rivals Nanogen and Affymetrix (see BAN 4/20/2005, BAN 7/27/2001). DeCode signed an agreement with Affy in 2001 to "develop DNA-based tests for patient response to common disease treatments." At the time, the companies planned to conduct gene expression analysis on clinical trial populations to discover gene-expression patterns corresponding to responses to drugs for high cholesterol, depression, asthma, hypertension, breast cancer, schizophrenia, and migraine, and then develop and market chip-based diagnostic assays for drug response patterns (see BAN 7/27/2001).
Neither DeCode nor Affymetrix responded to inquiries regarding the outcome or status of the 5-year-old agreement by press time. Affymetrix has not publicly discussed its relationship with DeCode Genetics since 2001.
More to Come?
According to Illumina, the DeCode alliance is the leading edge of what it hopes will be a major genotyping market expansion into the pharmaceutical and biotech arenas.
During a conference call discussing first-quarter results last month, Illumina CEO Jay Flatley stressed that more biotechs and pharmas would begin adopting the company's technology.
"The pharma and biotech industries are just beginning to adopt whole-genome genotyping," Flatley said. "We believe that the clinical trial, pharmacogenomics, and post-market surveillance opportunities [for genotyping] will be much larger than the research opportunities." (see BAN 4/25/2006)
Earlier this month, Flatley told investors at a Deutsche Bank Health Care Conference in Boston that whole-genome genotyping was the "highest growth area for the company." Illumina's first-quarter results surpassed its original estimates for the quarter.
However, Flatley acknowledged that most of that revenue had come through deals with large research foundations like the Wellcome Trust Sanger Institute and Cancer Research UK, both of which signed multimillion dollar deals with Illumina last year (see BAN 10/5/2005, BAN 11/16/2005).
"There's some skepticism out in the industry over whether we are seeing a boom in [whole-genome genotyping] and whether or not this is all going to disappear in a year," he said during the conference. Flatley reiterated Illumina's projections that the genotyping market could become a multibillion dollar market over the next five years. He also acknowledged that penetrating the biotech and pharmaceutical markets was a priority for the company.
According to Illumina spokesperson Bill Craumer, Illumina expects to close additional deals similar to the DeCode alliance by the end of the year. "We have told investors that we want to sign two or three diagnostic deals," Craumer told BioArray News this week. "This will be one of those deals."
— Justin Petrone ([email protected])