NGS devices get US-FDA approval

[ymc]

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?

[austinso]

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.

[GenoMax]

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

[austinso]

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

[GenoMax]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htm