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Illumina Debuts BeadXpress, Hopes FDA Will See First Dxs in '08; Homebrew Options Open

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Illumina this week launched its BeadXpress system, a platform for research and clinical development applications that uses its VeraCode digital microbead technology, rather than its arrays, as its foundation.
 
The company said it has signed four collaborations since May 2006 to use the BeadXpress as a platform to deploy diagnostic content. Illumina also said it could file tests for US regulatory approval sometime next year, and BeadXpress customers may in the future use the platform to develop homebrew tests.
 
The launch of the BeadXpress could also give Illumina an edge in the budding genetic-testing market. While debate over what platform to use in multiplex diagnostic assays tends to include RT-PCR and microarrays, the BeadXpress system relies on a lesser-known method that uses laser detection to read microbeads.
 
Illumina CEO Jay Flatley said the company decided to develop the BeadXpress system rather than tweak its existing line of genotyping and gene-expression chips for diagnostics because it believed that the ideal diagnostic platform would perform best in a multiplex range lower than what most microarrays can provide, yet higher than what most RT-PCR assays can yield.
 
"The sweet spot for diagnostic applications will be at multiplex levels between 10 and 150 markers," Flatley wrote in an e-mail to BioArray News this week. "Microarrays are overkill at this level of complexity and do not offer the flexibility or cost dynamics that this market demands."
 
Illumina acquired the VeraCode technology through its 2004 purchase of Wallingford, Conn.-based CyVera for $17.5 million. Two years later it penned a deal with DeCode Genetics that provided DeCode with a custom BeadLab for genotyping work and enabled Illumina to use DeCode-discovered biomarkers in future tests on the BeadXpress (see BAN 5/17/2006).
 
Initially, Illumina and DeCode said they were working on tests designed to help determine risk factors for developing type II diabetes, myocardial infarction, and breast cancer. Flatley declined to specify which of the applications would make it to market first, but this week wrote that DeCode and Illumina are "working closely" on a test for myocardial infarction.
 
Jeff Gulcher, chief scientific officer at DeCode, told BioArray News in an e-mail this week that DeCode is "targeting cardiovascular diseases and cancer using the BeadXpress platform" and "will use it to measure multiple DNA-based markers in the blood to determine a patient's risk for future disease, subtype of their current disease, or best therapeutic option for them."

Gulcher added that Illumina has projected that the “first kits would be submitted for US Food and Drug Administration approval in 2008." Flatley wrote that Illumina could file the tests for 510(k) or pre-market approval. He also said that in the future it is likely BeadXpress customers could use the platform to develop homebrew tests.

 
Illumina has initiated similar diagnostic partnerships with three other parties: Bangalore, India-based ReaMetrix, the Children's Hospital of Eastern Ontario, and Genizon Biosciences.
 
Sheri Miraglia, ReaMatrix’s vice president of business development and chief scientific officer, told BioArray News in July 2006 that the firm currently sells products for T-cell enumeration that are approved for diagnostics in India, and that the company is interested in “addressing” diseases such as Type II diabetes and cardiovascular disease (see BAN 7/25/2006). ReaMetrix did not respond to calls and e-mails seeking comment on the status of the program this week.
 

"Microarrays are overkill at this level of complexity and do not offer the flexibility or cost dynamics that this market demands."

In January, Illumina said that it will work with the Children's Hospital of Eastern Ontario to develop molecular tests that would screen infants for spinal muscular atrophy and blood diseases.
 
Genizon, a certified Illumina service provider, has also agreed to work with Illumina to develop tests related to osteoarthritis, Flatley wrote this week. He added that Illumina has "full responsibility for defining the test and the platform based on whatever biomarkers Genizon discovers."
 
The BeadXpress is still an unknown quantity, and it is hard to gauge how the market may react to it. Illumina said in a statement last week that it has shipped two systems to early-access customers Duke University and Johns Hopkins University.
 
Kevin Shianna, director of Duke University's genotyping facility, said in the statement that the facility will use the system in infectious disease and schizophrenia studies.
 
DeCode's Gulcher wrote last week that the firm decided to take a chance on the BeadXpress because of its experience with other Illumina technologies and because of flexibility in the assay that he felt is superior to RT-PCR and array technology.
 
"In our opinion BeadXpress offered more flexibility and cost-effectiveness for this type of diagnostic than their competition," he wrote. "To change a single SNP marker in an assay or to add another five markers to an already established assay of 40 SNPs would require many competitors to redesign the chip, tool up, and then manufacture the new chip," Gulcher wrote. 
 
"With BeadXpress, it requires only a simple and cost-effective change in one of the cylinders within the mix of cylinders that define the test. This flexibility is important for updates in the test and for developing several parallel versions of a panel that would better target certain patient subgroups," he added.

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