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Illumina Unveils Strategy to Enter Molecular Diagnostics Market

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Illumina plans to enter the molecular diagnostics space by forging partnerships with customers, opening a new CLIA lab, and launching a research project to study cancer genomes, CEO Jay Flatley said during a recent presentation to investors.

Speaking at the JPMorgan Healthcare Conference in San Francisco last week, Flatley said the company will invest to improve existing sequencing technologies and develop new ones to enable it to play in the molecular diagnostics space, which he estimates to be worth $3 billion.

"We are really excited about what's happening in the sequencing market," Flatley said during his presentation. "We think over the next few years, it's going to be the most exciting segment in life sciences tools, so we continue to make major investments in this space."

As part of what Flatley called Illumina's "platform partnering" program, the company plans to work with customers to develop diagnostic applications using its existing BeadXpress genotyping platform and the sequencing technology it acquired last summer when it bought Avantome.

With the BeadXpress platform, Illumina has already begun partnerships to develop genotyping assays for blood typing, pharmacogenomics, and prenatal testing, Flatley said. Illumina hopes to garner clearance from the US Food and Drug Administration for the BeadXpress platform in the second half of the year.

Illumina has yet to commercialize the Avantome technology. Flatley did not update investors on the types of sequencing-based diagnostic tests Illumina plans to develop with the Avantome platform, or the partners Illumina is working with on this effort.

Additionally, Illumina plans to open its own CLIA-certified diagnostic laboratory, which will allow the company to introduce tests and testing services while waiting for the US Food and Drug Administration to clear test kits being developed under its partnering program.

He said the CLIA lab will also enable Illumina to offer services based on proprietary content from its licensing and discovery programs, and to offer sequencing services for "traditional [genetic] targets" such as carrier testing for Rett syndrome; drug-resistance testing for HIV and Mycobacterium; mutation detection in the genes P53, KRAS, BRAF, EGFR; and HLA testing.

The company plans to apply for CLIA-certification during the first half of this year and hopes to start generating revenue from diagnostic services in the second half of 2009. An Illumina spokeswoman told PGx Reporter sister publication In Sequence this week that the company's primary interest for the CLIA lab is to provide sequencing services on its Genome Analyzer.

The last piece of Illumina's plan to enter the diagnostics space involves an internal discovery-research project to study ovarian and gastric cancer. To that end, the company plans this year to sequence approximately 50 cancer genomes and their controls, and to conduct whole-trascriptome and methylation-profiling analyses of these samples, Flatley said.

After validating the results in a larger number of samples, Illumina plans to implement diagnostic tests using these results on its array platform. Specifically, for ovarian cancer, Illumina aims to "identify very early markers for diagnosis" and to "begin to look at the genetics of therapy resistance, in particular resistance to platinum therapy," according to Flatley.

He said Illumina can embark on a project of this scale because "we can sequence so rapidly, and at such great cost points."

The decreasing cost of sequencing technologies has particularly impacted the nascent consumer genomics industry. Both 23andMe and Navigenics have said they plan to offer their customers whole-genome sequencing as the costs of this technology decrease.

Flatley told the JPMorgan conference that the molecular diagnostics market will grow from $3 billion to $5 billion by 2011, while the sequencing market will grow from $1.1 billion to $1.5 billion during that period. Illumina is betting that its sequencing know-how will enable it to win a slice of the broader molecular diagnostics space.

In this regard, Flatley said Illumina plans to launch several new products in the near term, including a sequencing add-on module, called Harmonia. The module works in concert with Illumina's iScan genotyping platform, set for launch in the second half of this year, and will be marketed to the company's genotyping customers who want to try sequencing technology.

Last week, as reported in In Sequence, Illumina announced it had made an $18 million investment into UK-based startup Oxford Nanopore Technologies. Oxford's nanopore sequencing technology "holds tremendous promise to be one of the first technologies to reach the sub-$1,000 genome and become the cheapest and fastest way to sequence DNA," Flatley said during his presentation (see In Sequence 1/13/2009)

Julia Karow, editor of In Sequence, contributed to this article.

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