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Old 11-20-2013, 06:47 AM   #1
GenoMax
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Default NGS devices get US-FDA approval

http://www.fda.gov/NewsEvents/Newsro.../ucm375742.htm
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Old 11-23-2013, 07:41 PM   #2
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Caveat is that it can only handle up to V2 chemistry.
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Old 11-24-2013, 04:09 AM   #3
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Not surprising. There will likely be no "user serviceable parts" in MiSeqDX. Approval is for specific version of MCS/chemistry/analysis software.

This application may need a new purchase i.e. an existing MiSeq probably can't be upgraded to a MiSeqDX.

Looks like the pages for Molecular Diagnostics are already up: http://www.illumina.com/clinical/diagnostics.ilmn
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Old 11-24-2013, 08:41 AM   #4
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In fact, the instrument would be a "downgrade" compared to what is out now from what I understand...the requirement of the FDA approval process that everything must be locked down prior to submission.

But, while this does open the door to FDA-approved reagents for NGS, there could be ramifications for current LDTs using sequencing given the CLIA vs. FDA ambiguity.
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Old 11-29-2013, 02:33 PM   #5
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I presume if you want to make a product out of this MiSeqDX, your interpretation software should also need FDA approval, right?

Are there any incentive for Foundation Medicine or OncoType DX to create an FDA-approved version of their test? It seems to me they can just keep marketing them as LDTs forever?
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