theranos

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I just cannot fathom that a lab that styles itself as a national reference lab would have significant deficiencies on inspection related to lab director and lab supervisor roles. It's almost like they didn't bother to read the regulations and laws governing the business they were entering.

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I was wondering if Cleveland clinic ever started doing those studies. Sounds like they didn't.

Hopefully Theranos will burn through that 750 million fast so we never have to hear from them again. I can't believe the people that write these articles wonder if they can "right the ship" or "mount a comeback".
 
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Allowing patients to order own lab tests is like letting them to bless the holy water instead of a the clergy.

Insurance won't pay for sure without an ICD-10 code so how is that gonna happen?

Has anyone one read ANYTHING by Theranos? Doesn't Siemens verify/validate their testing??? :) If anything buy stock in Siemens. I'm with LADoc. If the Theranos founder looked like Roseanne Barr would she have this following? Their business model seems cash only send in's that no private practice clinician would base medical judgement off of at the current time.
 
You don't use insurance for direct access testing. Our lab dabbles in it since it's legal in our state. Come in, pay 35 bucks for a PSA, mail results to participants or physician office (if they want that). I'm not a fan of it since I am in the "less is more" camp and think most of health care is waste.

Theranos seems to be dodging any opportunity to show that their technology works. I was surprised that there wasn't even a timetable for cleveland clinic to do their studies. So now what for Theranos? Buy the same equipment the rest of us use, somehow setting up the infrastructure to compete with the labcorps and quests of the world and try to survive with those low prices? Good luck with that.
 
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A patient (client rather?) may not use insurance for direct testing but what that testing is abnormal? Insurance has no record for example a PSA was ordered, was abnormal, and now may need further evaluation? I'd bet my cookie from the cookie jar in order to have coverage for subsequent studies say a prostate biopsy, insurance will probably not cover that and if its done will deny payment.....etc.....etc....etc..... I'd think they would require proper documentation and billing in the right sequence pattern to shell out the tokens.

It must be nice to make the rules. :)

Will this help the poor? I'd bet they would rather spend the $$$ on cigarettes or beer or something versus "I'm curious about a getting a lab test." And why not just go to the ER and never pay the ER bill etc.? That's a common game.

I can see some nightmare of an appointment for a primary MD (or provider / NP / barf) having the hypochondriac of a patient ordering bushels of their own labs and bringing in stacks of results complicating management. Shudder. Jove knows how much extra time that would screw a primary care visit. Maybe NPs are a blessing in disguise to dump these types of patients on.
 
A patient (client rather?) may not use insurance for direct testing but what that testing is abnormal? Insurance has no record for example a PSA was ordered, was abnormal, and now may need further evaluation? I'd bet my cookie from the cookie jar in order to have coverage for subsequent studies say a prostate biopsy, insurance will probably not cover that and if its done will deny payment.....etc.....etc....etc..... I'd think they would require proper documentation and billing in the right sequence pattern to shell out the tokens.

It must be nice to make the rules. :)

Will this help the poor? I'd bet they would rather spend the $$$ on cigarettes or beer or something versus "I'm curious about a getting a lab test." And why not just go to the ER and never pay the ER bill etc.? That's a common game.

I can see some nightmare of an appointment for a primary MD (or provider / NP / barf) having the hypochondriac of a patient ordering bushels of their own labs and bringing in stacks of results complicating management. Shudder. Jove knows how much extra time that would screw a primary care visit. Maybe NPs are a blessing in disguise to dump these types of patients on.
Yeah, I'm all for patients paying cash for whatever blood work they want (my practice is cash-only and I operate this way), but if you bypass an ordering doctor then the lab is stuck with abnormal results. I can't think y'all really want that liability.
 
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Huh? Any indication what these shortcomings were? I'm not sure if this is a big deal for the profession of pathology, but I'm guessing not.
 
The physicians and insurance companies that sent patients there should be ashamed.

Hopefully this is the end of them. My guess is that they hang around until they burn through all that cash, which shouldn't be too much longer I would think.
 
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I'm no lover of Theranos, but this is a bit of yellow journalism.

I'd wager that every experienced pathologist on this forum who has been involved in laboratory inspections and looked hard enough has encountered a lab where a tech released results after a QC failure or found expired reagents on a shelf or in use. I know I have. Hell, when the good QA supervisors find this sort of crap in one of their labs they have the printout, corrective action documentation, and memorandums of notification for patients and physicians in my hand the moment I set foot inside the lab for the inspection. The only labs I've ever called CAP about were the ones that tried to hide this sort of thing or had no idea it was going on.

The bigger issue for Theranos investors is that these laboratory practice deficiencies occurred in a lab THAT WASN'T EVEN USING THEIR PROPRIETARY EINSTIN INSTRUMENT THAT WAS SUPPOSED TO TURN THE CLINICAL LABORATORY INDUSTRY ON ITS HEAD. The way these billionaires were duped into pouring money into this company gets more astounding every day. I wouldn't be surprised if when they finally opened the Einstein instrument, they found a hamster running in a wheel.

I bet Roche and Abbott executives retire to the executive dining room every day that one of these articles comes out so they can cackle and draw Hitler mustaches on pictures of Liz Holmes.
 
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Doesn't sound like any action was taken until after CMS came. I can't tell if they had any idea there was a problem or tried to hide it. The previous california lab director was a freaking dermatologist! Sounds like it was a mickey mouse operation. At least the new director is an actual pathologist.

The Edison instrument (I wrongly keep calling it Einstein) may never see the light of day. It's probably heading to the lab equipment boneyard. Investors wasted a lot of money as they essentially gave money to a labcorp/quest wannabe with technology that doesn't appear ready for primetime.
 
I'm no lover of Theranos, but this is a bit of yellow journalism.

I'd wager that every experienced pathologist on this forum who has been involved in laboratory inspections and looked hard enough has encountered a lab where a tech released results after a QC failure or found expired reagents on a shelf or in use. I know I have. Hell, when the good QA supervisors find this sort of crap in one of their labs they have the printout, corrective action documentation, and memorandums of notification for patients and physicians in my hand the moment I set foot inside the lab for the inspection. The only labs I've ever called CAP about were the ones that tried to hide this sort of thing or had no idea it was going on.

The bigger issue for Theranos investors is that these laboratory practice deficiencies occurred in a lab THAT WASN'T EVEN USING THEIR PROPRIETARY EINSTIN INSTRUMENT THAT WAS SUPPOSED TO TURN THE CLINICAL LABORATORY INDUSTRY ON ITS HEAD. The way these billionaires were duped into pouring money into this company gets more astounding every day. I wouldn't be surprised if when they finally opened the Einstein instrument, they found a hamster running in a wheel.

I bet Roche and Abbott executives retire to the executive dining room every day that one of these articles comes out so they can cackle and draw Hitler mustaches on pictures of Liz Holmes.
Spot on. I believe that the abuses were likely far more egregious, but that's all they found on their last CAP inspection. The lack of a medical director probably just threw inspectors for a loop. The big problem here is FRAUD. Not bad lab practices. They just needed a reason to shut them down before any more damage was done to the lab industry.
 
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Somebody on twitter posted this quote, which is pretty funny

"New polls by Theranos indicate Hillary is up 3 points, down 24 points, down by 15, up by 47 against Bernie."
 
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This whole situation is so weird. The fact that so many people would sink so much money into this company without really validating whether their technology worked is weird. People with $ usually don't throw it at unproven tech. But maybe healthcare is different. Maybe it's easy to make it sound easier than it is.

And this technology is not super rare, other companies are working on it to run tests on really small samples of blood (or even without drawing blood at all!). What about this company made their pitch so potentially lucrative? Was it the potential to be in every walgreens or something?

And then when problems start to come out, some of them seem to be overblown. Obviously the intense focus makes it difficult, but no doubt some of the citations were common things that well run labs receive too. Maybe the major problem is that they have done themselves ZERO favors by their public relations strategy of blaming lab corp for every criticism, continuously claiming how rigorous their validations were, touting minor achievements, etc. And initially they deflected much of the hard questions by trotting out the founder for fawning profiles to less medically-savvy media.

So I don't get it. Does the technology really not work, or are they just unlucky in how things have broken out so far? Did they think they validated things but in actuality their validation methods were significantly flawed?

Meantime, how is it that they keep functioning? Huge cash reserves? Secret silent backers?
 
This is not weird, this is by product of the lunacy at Stanford/Silicon Valley that is occurring all the time.
 
"One key question that wasn’t addressed in the Mount Sinai study is whether Theranos used its proprietary devices to run those tests.

Test reports provided to patients show that the tests were run at the company’s lab in Newark, Calif. That lab has Theranos’s proprietary Edison devices and traditional lab machines bought from diagnostic-equipment makers such as Siemens AG, according to former Theranos employees.

One former Theranos employee said the company wasn’t performing the 22 tests in question on Edison devices as recently as June 2015, or the month before the Mount Sinai tests.

Instead, Theranos was diluting small blood samples collected from fingers to increase the volume of those samples and then running them through traditional lab machines, according to the former employee."

the chemistry tech specialist in me is cringing here...
 
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"One key question that wasn’t addressed in the Mount Sinai study is whether Theranos used its proprietary devices to run those tests.

Test reports provided to patients show that the tests were run at the company’s lab in Newark, Calif. That lab has Theranos’s proprietary Edison devices and traditional lab machines bought from diagnostic-equipment makers such as Siemens AG, according to former Theranos employees.

One former Theranos employee said the company wasn’t performing the 22 tests in question on Edison devices as recently as June 2015, or the month before the Mount Sinai tests.

Instead, Theranos was diluting small blood samples collected from fingers to increase the volume of those samples and then running them through traditional lab machines, according to the former employee."

the chemistry tech specialist in me is cringing here...

Absolutely right. We have no clue how these were handled only that they did a finger prick.
Kind of key limitation of the study.
 
The report from TechInsider said that Theranos confirmed the tests were run on Theranos technology.
 
Wall Street journal is saying tests were run on Edison.

Bottom line about Theranos: they shouldn't be allowed to "re-boot" and become a labcorp/quest clone using traditional equipment. They have been secretive and reckless. I have a feeling their name is so tarnished it won't be possible anyways. The PT/INR problems on traditional equipment and now the curtain being removed from Edison. Thank you Wall Street Journal once again.
Game over. :boom:
 
Like Jackson and Bee at Manassas, Theranos has regrouped and launched the counterattack.

Looks like they intend to "give them the bayonet".

http://www.businesswire.com/news/ho...unces-Leading-Medical-Laboratory-Experts-Join
Too little, too late IMHO. Industry is all about opinion and credibility. They have lost it. Don't expect any more $$ until there are real tangible profits from this company. There is no more venture $ to play with and develop (beyond what they have).
 
LADoc was right about them. They are going to end up like 23 and me. Maybe they become an internet company now. Walgreens will be giving them the boot at some point.
 
Even more bad news for them: http://www.vox.com/2016/4/13/11424130/theranos-elizabeth-holmes-banned

latest
 
If she is the genius that she is ballyhooed to be, she will grab as much money as she can as quickly as she can and move to a comfy non-extradition paradise.
 
Their toast. How long before Walgreen boots them out?
 
My husband founded and runs a tech start-up, deals with his board, investors, VC etc. Venture capitalists are extremely ageist and sexist already. He is routinely told, "You don't look old enough to be a CEO." Many VCs will not invest in a company if the CEO is not a certain age. In spite of how the media makes things look, VCs are usually pretty careful - or they try to be, for a bunch of rich dudes with pretty high risk tolerance. They do not trust youth, and there are virtually NO women pitching ideas. It is absolutely UNHEARD of that a female would raise this kind of money for a start-up. In the history of tech it has never happened on this scale.

And now, thanks to her idiocy, VCs will simply not give a meeting to a young female in the future. Why should they? She has botched the entire start-up universe and done a severe disservice to any female entrepreneur. And has made VCs wary of promises from medical startups. While medical startups are still being funded left and right, none will reach this valuation and none will raise this kind of money. VCs are not really that innovative. From what I can see, it is a boys' club and they just follow what the others are doing.

She has a much bigger problem than not being allowed to run a lab for 2 years. She has a much bigger problem than figuring out where to hide her money. She will probably wind up getting sued for investor fraud.

http://www.businesswire.com/news/ho...Investigation-Theranos-Inc.’s-Representations


I read one interview with her where she said that growing up, her parents told her anything was possible if she believed it enough, to never take no for an answer, and that she was a wonderful snowflake. That is the wrong attitude to give your kids. Not saying you should tell your kids the opposite, just that to make a person unaware of any boundaries whatsoever is really stupid. It leads to some cognitive dissonance and reality will come knocking eventually.....

Here is a cute quote:

Avoid backup plans.
“I think that the minute that you have a backup plan, you’ve admitted that you’re not going to succeed,” Holmes says.

Well, that was dumb.
 
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I still can't really fathom why they thought they could succeed so much without having much laboratory experience involved. They were a new company, trying to run essentially like a large reference lab, but yet their board had no one with any lab experience and their lab director was a dermatologist? Calls to mind whether the lab director actually had any say in how the lab ran. I just don't get it. The public relations too - blaming lab corp for any criticisms, talking about how transparent they are while hiding everything, it just goes on. I think it's a great lesson for future companies - don't think you can dodge and hide when your business is potentially so public and it includes data that people need to see in order to trust. And if you're going to "disrupt" an industry, you should probably at least try to understand it from the inside, and not just from the outside.
 
Breaking news on Bloomberg--Theranos is under investigation by the SEC and (wait for it) the U.S. Attorney's office in California. I said she should have split. Now it's too late.
 
The tl;dr from the latest Lab Econ is damning:

The lab director spent the majority of his time signing out derm in his private practice rather than doing QC/QM for the lab. Two technical supervisors didn't have the requisite training or experience. They had a liberal arts major with no lab training working the benches.

HFS, she might as well have hired a PGY IV to run the place; might have gotten better results.
 
Holmes gave an interview, which was a joke, to Maria Shriver yesterday. Too bad NBC didn't use a real journalist. Holmes was allowed to just plead ignorance. Investors got screwed, patients got screwed. She needs to answer for it all. I can't wait to hear what exactly investors were told about the technology. Hopefully this criminal investigation will bring that to light.

Theranos reminds me of those asian "massage" parlors that pop up in small towns. You just knew there was shady stuff going on.
 
Holmes gave an interview, which was a joke, to Maria Shriver yesterday. Too bad NBC didn't use a real journalist. Holmes was allowed to just plead ignorance. Investors got screwed, patients got screwed. She needs to answer for it all. I can't wait to hear what exactly investors were told about the technology. Hopefully this criminal investigation will bring that to light.

Theranos reminds me of those asian "massage" parlors that pop up in small towns. You just knew there was shady stuff going on.
I am not sure that nbc "news" is not a bigger fraud than Theranos.

Given that only 6% of American trust the news media, this interview speaks for itself.
 
Federal criminal investigation article in NYT:

http://www.nytimes.com/2016/04/19/business/theranos-sec-justice-department-investigation.html?_r=0

She says she is so super devastated.

http://arstechnica.com/science/2016...stated-by-companys-failures-claims-ignorance/

On an unrelated note, I saw my buddy who is a former "private biotech company" employee over the weekend. Without violating any confidential privilege, or disclosing any company secrets, or implicating anyone in any criminal activity, this person was able to give an impression about working at a "private biotech company" which intrigued. It seems that at some "private biotech companies" all is as strange on the inside as it appears from the outside.
 
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A real problem here is that it is possible investors were not misled. One would think that all investors are always extremely diligent, but this is not the case. A lot of people with a lot of money in Silicon Valley jump on a bandwagon when something seems like a "sure thing" and everyone else is doing it. They are more critical of smaller investments in smaller companies where they will be the largest single investor, and sometimes overlook better technology from smaller companies because of it. When all their buddies are doing it, they may assume that "someone" has looked into it and there has been diligence performed by "someone" and they just want to get in early enough to maximize their investment. So they will literally tell the attorneys to cram it when they try to do diligence in such a rabid situation.

Therefore, it is perfectly possible that a lot of investors did no diligence whatsoever, and therefore were not misled by anyone.

Of course no one knows until they start talking...
 
If you look at Theranos' website/advertisments early on, it was all about the nanotainer and the capability to run hundreds of lab tests with a small about of blood on THEIR equipment with complete price transparency. I doubt their sales pitch resembled what they have become-venous draws, using the same equipment others do, losing hundreds of dollars on sendout tests etc.

There is definitely more to be revealed. Can't wait to see what the investigation shows. Wall Street journal will surely cover it. They have done an amazing job. Maria Shriver was amateur hour yesterday, worse than Jim Cramer's interview. The liberal networks let her off way to easy.
 
Actually I have been told that if one uses the website "the way back machine" to see the original website pages of theranos (which I have not personally done) you can see that the original testing they touted was something along the lines of testing for drug companies to see which patients were going to respond differently to drugs and experience certain side effects or something along those lines.

As I have not looked this up specifically, I am not sure of what methods they claimed to use at that time. But it does explain why some of their earliest investors were drug giants who have not invested in a very long time. And the original technology was not the nanotainer.
 
Holmes gave an interview, which was a joke, to Maria Shriver yesterday. Too bad NBC didn't use a real journalist. Holmes was allowed to just plead ignorance. Investors got screwed, patients got screwed. She needs to answer for it all. I can't wait to hear what exactly investors were told about the technology. Hopefully this criminal investigation will bring that to light.

Theranos reminds me of those asian "massage" parlors that pop up in small towns. You just knew there was shady stuff going on.
No, it is nothing like those massage parlors, because those result in a happy ending.
 
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