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Illumina Eyes MDx Revenue in 2009; Working on Genome Analyzer Improvements

SAN FRANCISCO (GenomeWeb News) – Illumina anticipates that its BeadXpress and assays that are currently in development will provide the firm’s first proprietary molecular diagnostic revenues in 2009, CEO Jay Flatley told investors today at the JPMorgan Healthcare Conference held here.
 
He said Illumina is working with Decode Genetics on developing molecular diagnostic assays that the firm hopes to launch next year. Illumina struck an alliance with Decode in May 2006, under which the firms are developing diagnostics for gene variants that Decode has shown to be risk factors for diseases such as type II diabetes, myocardial infarction, and breast cancer.
 
The firm launched its BeadXpress platform early last year for low-multiplex research applications with an eye toward releasing molecular diagnostic assays for the system this year.
 
Flatley said Illumina expects to file initial assays with the US Food and Drug Administration later this year, but those would be intended to validate the BeadXpress platform as a clinical diagnostic platform rather than revenue generators.
 
Flatley’s comments followed the company’s announcement last week that it had reorganized into two new divisions — the Life Sciences Business Unit and the Diagnostics Business Unit — in order to take advantage of complementary capabilities in its genotyping and sequencing businesses and to focus more on its diagnostics business.
 
Flatley said today in response to a question about the firm’s M&A plans that although Illumina intends to initially develop molecular diagnostics content organically, it would look at potential acquisitions to build content or its distribution capabilities.
 
Company officials also provided an update on sales and development efforts for the firm’s next-generation sequencing product, the Genome Analyzer. Flatley said that Illumina has now sold more than 200 systems, which have all been shipped, although not all of the revenue from those systems has been received yet.
 
The firm is hoping that new developments, including paired end reads and increasing the amount of data per run for the system, will help drive further adoption. Currently, the Genome Analyzer provides 1 gigabases per run, but Flatley said that internally Illumina has been able to do 3 gigabases per run.
 
He also said that the firm is entering the second beta testing phase for paired end reads on the system. The first phase included around five beta sites, and the second phase will include roughly 10 beta testers, though Flatley didn’t name any of them.
 
Flatley said the Genome Analyzer has been rapidly penetrating the sequencing market, which he said would be worth roughly $1.5 billion in three to four years, driven by applications such as digital gene expression, whole-genome methylation, and chromatin immunoprecipitation-sequencing. He noted that Illumina is developing whole-transcriptome applications for digital gene expression.  
 
Illumina also announced at the conference that it had launched its new Infinium HD product line, which doubles sample throughput and reduces DNA input requirements for its genotyping chips by as much as 70 percent. The initial products for the line include the Infinium HD Human1M-Duo, which has two samples per chip, and the Human610-Quad, which has four samples per chip.
 
Both arrays on the Human1M-Duo BeadChip contain markers for more than one million diverse genetic variants, all of which can be used for both whole-genome genotyping and copy number variation analysis, Illumina said. The Human610-Quad BeadChip has 550,000 SNPs and an additional 60,000 genetic markers per sample.

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