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GenoMax 11-20-2013 06:47 AM

NGS devices get US-FDA approval

austinso 11-23-2013 07:41 PM

Caveat is that it can only handle up to V2 chemistry.

GenoMax 11-24-2013 04:09 AM

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:

austinso 11-24-2013 08:41 AM

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.

ymc 11-29-2013 02:33 PM

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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