[pen2l]

Walgreens recently halted all Theranos expansions (currently only 41 Walgreens have Theranos centers... there were plans to expand to many more): http://techcrunch.com/2015/10/23/walgreens-halts-theranos-te...

And it recently came to light that Elizabeth Holmes was misleading people when she said her company voluntarily stopped using nanotainers -- it seems she was forced to stop by FDA: http://www.nytimes.com/2015/10/28/business/theranos-quality-...

Between all of this, FDA coming in for tests, and other strange things, it seems they have a lot of answering to do.

Or, alternatively, them being in stealth mode is the reason for all of these strange happenings and lack of better information out there.

[joezydeco]

How can you perform live tests on patients and still be in stealth mode?

At some point you have to come clean with the FDA about your technology, right? Or is this considered a wide-field clinical trial?

[tvladeck]

> How can you perform live tests on patients and still be in stealth mode?

That really hit the nail on the head for me.

[msandford]

From an old article on the subject: http://fortune.com/2014/06/12/theranos-blood-holmes/

The tl;dr is that Theranos makes their own machines, which makes every test that they perform technically a "Lab Developed Test" LDT which doesn't have the same oversight that machines which are sold to others. As long as they make their machines and use their machines, they're effectively exploiting a loophole.

From the article:

The backdrop for this dispute is an unusual regulatory structure that does, in fact, confer upon some–though not all–conventional lab tests an extra layer of validation that Theranos’s do not yet have. Most labs, like Quest and Laboratory Corp. of America, perform many of their routine tests using analyzers they buy from medical-device manufacturers, like Siemens, Olympus, and Beckman Coulter. Before those manufacturers can sell such equipment, they must obtain U.S. Food and Drug Administration approval for the tests those analyzers perform–a process that is in addition to, and more searching than, the audits and proficiency tests required to win CMS certification for the lab itself.

At the same time, for other procedures conventional labs will devise their own lab-developed tests, or LDTs, which they do not have cleared by the FDA. While the FDA takes the position that it could require approval for LDTs, for many years it has said it would forgo that right in the exercise of its “enforcement discretion.”

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.

[joezydeco]

Beautiful explanation. Thanks.