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Old 11-29-2013, 02:33 PM   #5
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Location: Hong Kong

Join Date: Mar 2010
Posts: 498

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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