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Illumina, DeCode Genetics, Osmetech, FDA, Genizon BioSciences

Illumina Eyes MDx Revenue in 2009; Reorganizes Chips and Sequencer into One Unit
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 this week at the JPMorgan Healthcare Conference in San Francisco.
As BioArray News’ sister publication GenomeWeb Daily News reported, Flatley 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.
The life sciences segment will provide all of Illumina’s products and services related to the research market including the BeadArray, BeadXpress, and sequencing product lines.
Flatley said in a statement that the reorganization will result in “the acceleration of the integration of our sequencing and genotyping technologies. Additionally, it will enable us to put more focus on developing our diagnostics business.”
Illumina did respond to questions about the reorganization by press time.

Osmetech Submits Warfarin Sensitivity Test to FDA
Osmetech said this week that it has submitted to the US Food and Drug Administration a test to identify patients who are at risk for sensitivity to the blood-thinner warfarin.
Osmetech said it conducted studies for the eSensor 2C9/VKOR test on its eSensor XT-8 array system at three evaluation sites, and that pre-clinical studies completed in November 2007 showed the test to be in agreement with results from bidirectional DNA sequencing.
In August, the FDA updated its label for warfarin to explain that an individual’s genetic makeup may influence response to a drug and may influence optimal dosing.
Osmetech’s CEO, James White, said the company is confident that it will receive clearance from the FDA for the test in the first half of this year.

Genizon Raises $31M to Support Genome-Wide Association Studies for Metabolic Syndrome
Genizon BioSciences said last week that it has closed a Series E financing round worth CAD$31 million (US$30.8 million) that it will use to support genome-wide association studies for metabolic syndrome.
BTF, a venture capital fund based in the Netherlands, was the lead investor for the round.
Genizon, which is also a certified Illumina service provider, said the new financing brings its total funding since it was founded in 1999 to more than $130 million.
The company said it will use the new funding to support genome-wide association studies in obesity, type 2 diabetes, dyslipidemia, and hypertension. The company said it will also evaluate links between metabolic syndrome, coronary heart disease, and Alzheimer's disease, and will study genes it has discovered in longevity “that appear to protect against these diseases.”

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.