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The Whole Picture

The recent clearance of Illumina's MiSeqDx by the US Food and Drug Administration has gotten clinicians and researchers excited, writes Melissa Healy at the Los Angeles Times.

In November, FDA cleared Illumina's MiSeqDx system as well as three related assays. The company plans to market the platform for about $125,000, Healy notes.

Having such a machine in the clinic, she says, will enable physicians to order a test to look at patients' genomes wholesale rather than going through it gene by gene with targeted tests. "Why would you study just a few genes when you can see the whole thing?" Stanford University's Michael Snyder tells her.

Healy adds, though, that communicating what all this new information means to patients is a challenge. "We know that people get state-of-the-art genetic counseling and still walk out of that office confused," Harvard Medical School's Robert Green says.

Still, the clearance of the Illumina platform may pave the way for other systems. "We certainly hope to see more [platforms like MiSeqDx]," FDA's Elizabeth Mansfield tells Healy. "Bring it on."

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