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MiSeq Needs to 'Stabilize' Prior to FDA Submission, Illumina CEO Says


By Julia Karow

This article was originally published Dec. 2.

Illumina is seeing "tremendous uptake" of its MiSeq platform for targeted clinical sequencing as the company prepares to submit the instrument to the US Food and Drug Administration for approval next year.

At the Piper Jaffray Healthcare Conference last week, Illumina CEO Jay Flatley said that of the backlog orders for MiSeq so far, about 30 percent will have clinical applications. Among Illumina's customers, "almost everybody talks about sequencing clinically," he said. "That's the next wave of where these technologies can go."

Several users of "technologies like MiSeq" have already launched cancer gene panels of about 20 to 100 genes, he said. Though he did not mention specific examples, a lab at Washington University School of Medicine recently started offering a diagnostic cancer panel on HiSeq, which it plans to move to MiSeq (CSN 11/30/2011). Also, a lab at Baylor College of Medicine is about to launch a cancer panel on the Ion Torrent PGM, MiSeq's rival (CSN 11/30/2011).

Flatley said during his presentation, which was webcast, that Illumina plans to develop so-called "reference panels" for the clinical market, which customers will be able to use and improve over time.

The new clinically focused business unit that Illumina is implementing as part of its recent restructuring will have its own sales team, as well as marketing, commercial, and development activities, he said. It will focus on third parties who use Illumina's technology "to create new applications in the clinical market."

Regarding the submission of the MiSeq to the FDA, which Illumina plans by the end of 2012, Flatley said that it will be important for the technology to be "stabilized," meaning no more changes in software or hardware.

"Once customers start buying an FDA-approved box, they don't want to change that box," he said. At the moment, he added, the platform is still undergoing multiple changes in order to reduce its cost and improve its software.

Illumina is working closely with Siemens Healthcare Diagnostics to submit an HIV assay that Siemens is developing for the MiSeq to the FDA (CSN 11/9/11). That assay, he said, "may be the first submission" for MiSeq to the FDA, though the company has not yet decided on the first assay.

Submitting the HiSeq for FDA approval will be "a bit more challenging" because that instrument is more complex and is likely to have fewer clinical users than the MiSeq, Flatley said.

In the future, Illumina will likely sell two versions of MiSeq, he said — an FDA-approved version, and a research version.

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

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