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Illumina Sees Clinical Applications for MiSeq; Plans FDA Submission in 2012

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By Julia Karow

This article was originally published Aug. 2.

Illumina believes that its MiSeq desktop sequencing platform, currently in the hands of early-access customers, will be suitable for clinical applications and plans to apply for clearance of the system with the US Food and Drug Administration next year.

During a conference call to discuss the company's second-quarter earnings last week, CEO Jay Flatley said that the "most exciting area" for MiSeq, which is due to ship more broadly to customers in the fourth quarter, is clinical applications.

"We have a very large number of customers coming to us saying that they want to build targeted clinical panels," Flatley said, and the TruSeq custom enrichment kit that Illumina recently launched will make it "very easy" for them to design such panels for MiSeq.

According to CFO Christian Henry, one MiSeq customer plans to use the instrument to screen patients in the intensive care unit of a hospital for methicillin-resistant Staphylococcus aureus. He provided no further information about the customer. The example, he said, "gives you some perspective, or visualization, on how a system like this could be used in a hospital setting in places where we never even thought of it before."

To enable more clinical applications for MiSeq, Illumina has said previously that it plans to submit the platform for 510(k) approval from the FDA (IS 1/18/2011). Flatley added last week that the company is "actively working" on a submission for mid- to late 2012.

He said the company first needs to wait until MiSeq has been at customer sites for some time, so "the rate of change of the product is very low" and its configuration is locked, prior to selecting an assay to submit with the instrument for FDA clearance.


Have topics you'd like to see covered in Clinical Sequencing News? Contact the editor at jkarow [at] genomeweb [.] com.

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