And the even more original glowing and fawning cover story they did on Holmes in 2014: https://archive.md/XN6i6
> Precisely how Theranos accomplishes all these amazing feats is a trade secret. Holmes will only say–and this is more than she has ever said before–that her company uses “the same fundamental chemical methods” as existing labs do. Its advances relate to “optimizing the chemistry” and “leveraging software” to permit those conventional methods to work with tiny sample volumes.
Interesting how that reads in retrospect
> Holmes counters that because, as noted, her tests employ “the same fundamental chemical methods” as existing tests, peer-review publication of validation studies is both unnecessary and inappropriate.
Incredibly arrogant to the end fits well with her past behaviour
> Theranos, which does not buy any analyzers from third parties, is therefore in a unique position. While it would need FDA approval to sell its own analyzers to other labs, it doesn’t do that. It uses its analyzers only in its own CMS-certified lab. All its tests are therefore LDTs, effectively exempt from FDA oversight.
https://fortune.com/2015/12/20/letter-to-the-editor-theranos...
https://archive.md/NE7NB
Really quite something.
Original story: https://archive.md/BpOhV
And the even more original glowing and fawning cover story they did on Holmes in 2014: https://archive.md/XN6i6
> Precisely how Theranos accomplishes all these amazing feats is a trade secret. Holmes will only say–and this is more than she has ever said before–that her company uses “the same fundamental chemical methods” as existing labs do. Its advances relate to “optimizing the chemistry” and “leveraging software” to permit those conventional methods to work with tiny sample volumes.
Interesting how that reads in retrospect
> Holmes counters that because, as noted, her tests employ “the same fundamental chemical methods” as existing tests, peer-review publication of validation studies is both unnecessary and inappropriate.
Incredibly arrogant to the end fits well with her past behaviour
> Theranos, which does not buy any analyzers from third parties, is therefore in a unique position. While it would need FDA approval to sell its own analyzers to other labs, it doesn’t do that. It uses its analyzers only in its own CMS-certified lab. All its tests are therefore LDTs, effectively exempt from FDA oversight.