It's worth noting that (many) blood tests don't need FDA approval. This makes Theranos' approach unusual: they are getting FDA approval, but not publishing the (easier and cheaper to do) tests.
I don't know enough to judge this one in any sensible way. I thought this Forbes article[1] was good, and the author said:
How much is real and how much is hype? I’m not going to provide a final answer here. I still have no idea how Theranos’ technology works. But I’m more confident than I was before after spending a day talking to the company’s partners.
Here are a few reasons for that confidence: The Food and Drug Administration has just posted a detailed explanation of its decision to clear Theranos’ one approved test, and, to my eyes, it does give some validation of their technology
That's not quite true. They don't need expensive clinical trials like a drug developer would, but there is a regulatory process for getting FDA approval for diagnostic tests that lets companies self-regulate, as long as an FDA approved "lab manager" signs off on the internal validation process run by the company. They would only have to fall back to regular approval processes if there is no "golden standard" diagnostic test which to compare their test with.
I'm a bit dubious of using their partners as a source for the technologies effectiveness though. From the insurer's point of view they are getting extremely cheap blood tests from a company using the same equipment and methods as any other lab. Thats a great thing for the customer and the insurer but why would either care whether shifting to the proprietary technology gets approved?
I don't know enough to judge this one in any sensible way. I thought this Forbes article[1] was good, and the author said:
How much is real and how much is hype? I’m not going to provide a final answer here. I still have no idea how Theranos’ technology works. But I’m more confident than I was before after spending a day talking to the company’s partners.
Here are a few reasons for that confidence: The Food and Drug Administration has just posted a detailed explanation of its decision to clear Theranos’ one approved test, and, to my eyes, it does give some validation of their technology
[1] http://www.forbes.com/sites/matthewherper/2015/07/15/giving-...