theranos

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Is it just me or does this medscape article seem a bit slanted? Or at the very least, weak?
http://www.medscape.com/viewarticle/852839
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Sounds like they need to worry about their satellite labs more than Theranos.

Just shows what a joke CAP inspections are since they just passed one. You can't adequately survey someone in 4 hours. Either cut the checklist down or give people more time. It's a mad dash to get out of there by a reasonable time. We have had some long travel days to the labs we inspect. 2.5 to 3 hours one way in a car with a bunch of lab workers (aka women) sucks.
 
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What's the benefit in performing unpaid CAP inspections?
 
Benefits: nice to interact with coworkers, become familiar with checklists/requirements, interesting to see how other labs function, steal ideas, network.
Usually you find out that the grass isn't greener at other labs so it makes you feel a little better about where you work.
 
Departments could collaborate without having to do it under the auspices of a CAP inspection. I personally do not take part in CAP inspections nor would I if asked. It just doesn't make sense to me to provide professional services for free to a corporation that enjoys enormous profits based on the free work pathologists provide.
 
But if your lab is paying CAP for the inspection anyway, what's the difference if the person who is inspecting your lab is paid or not? You're still paying for the service anyway, its just not going to the inspector. I'm struggling to make sense of this.
 
If you google Theranos each day, there are many new articles. Today there is one about they are going to change their board (kick Kissinger and others to the curb).

Anyone going to dress up like Elizabeth Holmes for Halloween? Looks very easy to do. All black clothes, use a lot of hand gestures when you talk...
 
This quote from Holmes should make it completely obvious that she is full of ****. She can't even explain a process she apparently created actually works. Here is the quote: "A chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result, which is then reviewed by certified laboratory personnel." She added that, thanks to "miniaturization and automation, we are able to handle these tiny samples."
 
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PainDrain said:
This quote from Holmes should make it completely obvious that she is full of ****. She can't even explain a process she apparently created actually works. Here is the quote: "A chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result, which is then reviewed by certified laboratory personnel." She added that, thanks to "miniaturization and automation, we are able to handle these tiny samples."
Click to expand...

Ummm...that describes EVERY lab test.
 
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At least the company has stopped some of their alternatingly passive-aggressive and sometimes hostile responses to questions. For awhile they were blaming any criticisms on people being beholden to quest or labcorp as if criticisms couldn't possibly be related to anything but competition. But now they are at least acknowledging it. And questions about data used to be answered with, "Our data is awesome and extensive, but you don't need to see it. By the way we have unprecendented transparency and integrity blah blah." They now seem to be acknowledging they need to show data. Did they finally talk to some actual doctors? Doctors need to be able to trust data. I can open up a lab in my garage that offers diagnostic tests for cancer on saliva and say they work, but unless I prove they work how is anyone going to trust it enough?

I think one of the interesting things is their limbo between FDA and CLIA regulation. FDA regulates testing systems, CLIA regulates the performance of the testing, right? But because they are making their own testing systems they maintain they don't technically need FDA clearance for their assay because it's a lab developed test. This I don't understand. They are presenting their work with the FDA as some sort of glorious self-sacrificing move. But in truth, here is what they are doing:

They are inventing and building their own machines which perform assays for traditionally-measured things in the blood
They are shipping these machines to hundreds of pharmacies and other sites where they can be used to give quick results.

This is only at some very long stretch of the imagination equivalent to a "lab developed test." This would be like Siemens making a new analyzer then opening a clinic where they collected blood and ran it, but without clearing it with any regulatory authorities. Would anyone stand for this? I don't think so. This is not a lab developed test. This is a lab-owned and produced instrument which is then mass produced and distributed. This needs FDA clearance.

I continue to be mesmerized at their seeming lack of knowledge about anything related to the current practice of running a lab or performing tests. I suspect that they have hired people with knowledge, but either these people are being marginalized or ignored, or being paid to agree with whatever the bosses say. Seemingly nothing they say is really trustworthy. They say they aren't running any tests using their fingerstick technology until they get clearance but they clearly were, and they were not calling it a research study or anything.

I also still continue to wonder about the correlation between fingersticks and venipuncture. Not as concerned about it for assays like the one they already have been approved for (the HSV) because that's an ELISA and doesn't depend as much on concentration and blood chemistries. Until they show an excellent correlation between fingerstick and venipuncture for stuff like platelets, potassium, LDH, bili, protein, creatinine, etc I would not trust it. They say they have done this, but the data on their website just compares their results to "predicate," whatever that means. Another fingerstick? Venipuncture on a Siemens machine? Compared with what?

It may be a great technology but who knows.
 
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yaah said:
I continue to be mesmerized at their seeming lack of knowledge about anything related to the current practice of running a lab or performing tests. I suspect that they have hired people with knowledge, but either these people are being marginalized or ignored, or being paid to agree with whatever the bosses say. Seemingly nothing they say is really trustworthy. They say they aren't running any tests using their fingerstick technology until they get clearance but they clearly were, and they were not calling it a research study or anything.
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I'm sure their Dermatologist lab director is totally on top of it.

http://www.wsj.com/articles/theranos-searches-for-director-to-oversee-laboratory-1446770247
 
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Nice use of 350 million dollars Safeway...I can't believe how stupid these companies were.
 
Do you think this company will implode in a massive way or will they simply slowly downsize and/or rebrand themselves? I feel one of the massive VC firms will come in, boot Holmes, and rebrand the company as a competitor to the large lab corps. The worst part of all is Holmes will exit with a huge payday. Why is it if I committed fraud of this level I would go to a "f@'/ me in the @ss prison" while she walks away with hundreds of millions.
 
Good question. It is up to the investors. Is there enough cash to continue R&D and eventually prove the technology?
Getting new funding may be tough and I am sure the lab in Phoenix is not very profitable. I expect they burn cash daily.

If the venture capital folks that funded this feel they need to sue Homes, that's another matter. Criminal investigation might follow then.
 
Yeah I was waiting for that one. I guess she didn't mind that 100% of the puff piece stories about the company before the WSJ post were at least 50% about her and not the company. It's such a copout. There is definitely some out-of-bounds criticism directed at her, some based on her appearance, some based on her age and gender. But the majority of the criticism I have seen is about the company, not her personally. And I haven't seen any industry related criticism that has anything to do with her personally.
 
The script after the industry and media basically call you out on being a fraud is to claim sexism, racism, ect to try and deflect any criticism. I still cannot fathom why people in finance, VC, tech or whatever haven't called for a serious investigation of this company. It's a fraud.
 
I remember watching Ohio State's lab nearly get shut down a few years ago for sending out proficiency tests. How Theranos is allowed to even stay open is beyond me. If I were a patient, no way would I get testing done there.

The lady is different, wearing black turtlenecks all the time and claiming she needs little sleep due to her diet.
 
Adrian Cocot said:
http://www.wsj.com/articles/at-theranos-many-strategies-and-snags-1451259629

Yikes. The obfuscation, willful ignorance and sense of entitlement is palpable.
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After reading the latest WSJ article it is, as I have said before, amazing that this woman hasn't been called out as a complete fraud. Either everyone lies about their interactions with her or she is a complete con artist. Judging by the response of the Theranos PR person it would seem she is FOS. A head of a major VC firm said she was crazy. Former lead researchers say the technology is completely bogus and doesn't give valid results.
 
I thought they were FOS from day one. Their claims for the greatness of their technology was absurd.

They have no price advantage even if the technology worked.
They are just under bidding to grab market share. The business plan is to peel away the big box labs work before anyone noticed that really have crap.
 
PainDrain said:
A chemistry is performed so that a chemical reaction occurs and generates a signal from the chemical interaction with the sample, which is translated into a result, which is then reviewed by certified laboratory personnel
Click to expand...

This made me laugh out loud. Sounds like a bad MCAT tutor on the spot.
 
WEBB PINKERTON said:
Now the sexism card is being played....

http://fortune.com/2015/12/10/elizabeth-holmes-sexism-theranos/
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Ironic, it seems the reverse was what the media and co. tried to prop up in the first place. And, funny she suggests this card is being played when her "self-made billionaire" line is watered down considering it was all men who were the financial backers that gave her the 400 million in actual cash raised and they constitute the other 49% of ownership.

Holmes was supposed to be the grrrl powered answer to Steve Jobs, black turtleneck and all. Reality check: she quits school at 19 y.o. to run a medical technology startup in several areas where P.h.D's spend decades researching just one aspect of each, and we are supposed to accept the fact that she's got it all figured out, just like that? Got it.
 
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Theranos is building a lab in Pennsylvania I read somewhere. Hopefully this cancer will be stopped before they do more damage. Disappointing how our leaders have said virtually nothing as this has unfolded.
 
I am starting to wonder what their endgame is. It seems they want to establish a line of consumer directed test ordering which is efficient, cheap, and easy to find. That may be possible if they can make their technology actually work and work cheaply (including quality controls and proficiency testing and such), or if they manage to convince people that their testing is reliable. I had thought their endgame was to create a new methodology which would be cheaper and faster and more portable, but I'm not sure about that now. There are probably dozens of other companies working on testing that will be faster and more portable. Maybe not cheaper, but that's all relative anyway. Theranos can only undercut the price for so long before they run out of reserves and loans and have to actually start charging enough to make a profit. So if they want to sell their machines to others they obviously have to do a lot of work.

The whole issue of Laboratory Developed Test and the loopholes is an interesting side story. They are claiming that, despite the fact that they are manufacturing hundreds or thousands of analyzers and using them all over the country that their tests are the same thing as other "lab developed tests" which are typically modifications of existing assays like JAK-2 assays or FISH tests or whatever. I really can't see that holding water. That's like if Siemens or Beckmann decided to open up their own labs and say they no longer needed FDA approval because they were lab developed. Would anyone stand for that really? Ultimately though since they are testing for things that are commonly tested for elsewhere, they need to demonstrate that their results are rock solid equivalent of other existing assays. This isn't a new test, these are sodium, platelet counts, bilirubin, all things with known clinical impact and reference ranges. "Simple" tests which have to have reproducible and trusted results. You can't just say "trust us, our results are great" and get away with that.

And I see that they are still blaming criticisms on lab corp and the competition trying to bring them down. I don't understand their public relations at all. They act more like politicians or investment banks, dodging and weaving, being cryptic and hiding data, and blaming haters instead of answering actual questions. They seem to fail to realize that everyone hates politicians and investment banks and no one really trusts them. For certain industries that might be an ok strategy. For health care data that's not ok for most people.
 
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yaah said:
I am starting to wonder what their endgame is. It seems they want to establish a line of consumer directed test ordering which is efficient, cheap, and easy to find. That may be possible if they can make their technology actually work and work cheaply (including quality controls and proficiency testing and such), or if they manage to convince people that their testing is reliable. I had thought their endgame was to create a new methodology which would be cheaper and faster and more portable, but I'm not sure about that now. There are probably dozens of other companies working on testing that will be faster and more portable. Maybe not cheaper, but that's all relative anyway. Theranos can only undercut the price for so long before they run out of reserves and loans and have to actually start charging enough to make a profit. So if they want to sell their machines to others they obviously have to do a lot of work.

The whole issue of Laboratory Developed Test and the loopholes is an interesting side story. They are claiming that, despite the fact that they are manufacturing hundreds or thousands of analyzers and using them all over the country that their tests are the same thing as other "lab developed tests" which are typically modifications of existing assays like JAK-2 assays or FISH tests or whatever. I really can't see that holding water. That's like if Siemens or Beckmann decided to open up their own labs and say they no longer needed FDA approval because they were lab developed. Would anyone stand for that really? Ultimately though since they are testing for things that are commonly tested for elsewhere, they need to demonstrate that their results are rock solid equivalent of other existing assays. This isn't a new test, these are sodium, platelet counts, bilirubin, all things with known clinical impact and reference ranges. "Simple" tests which have to have reproducible and trusted results. You can't just say "trust us, our results are great" and get away with that.

And I see that they are still blaming criticisms on lab corp and the competition trying to bring them down. I don't understand their public relations at all. They act more like politicians or investment banks, dodging and weaving, being cryptic and hiding data, and blaming haters instead of answering actual questions. They seem to fail to realize that everyone hates politicians and investment banks and no one really trusts them. For certain industries that might be an ok strategy. For health care data that's not ok for most people.
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They're acting more like politicans bcause their board is composed of a bunch.

Reading the history of the company it sounds like they keep trying to come up with something revolutionary, falling short, then shifting gears to something else revolutionary. Just seems like some big egos wanting to make bank.
 
There is no "Endgame" here. The whole thing was an epic B.S. op conceived right after the net commerce bubble collapse in a place where B.S.ing is literally a full fledged Olympic Sport aka Stanford/Silicon Valley. The problem now is that instead of just fizzling out and going away, the primaries are so fully invested they can't do anything but continue the charade.

One scientist has already committed actual suicide. Expect more @ #MadoffBizPlan
 
Well I find it hard to believe they don't have any endgame. Can their plan really be to have this woman parade around to media outlets for fawning portrayals, then wait for $ to roll in? I don't think that many people would invest in BS. I suspect initial studies were promising and they had all kinds of projections showing what could happen with increasing business and such.

I mean, I can understand why older politicians and military types would be on the board. Easy paycheck. But who were/are all the investors? There can't have been that many people with significant lab experience investing $. Maybe that's part of the reason they are so pissed at Labcorp, maybe they offered labcorp part of the company.
 
I don't know if any of you are old enough to remember the dot com boom of the late 90s, but there was a company called WebVan. They were an online grocery deliver service that went from being worth 100s of millions to zilch in a few short years. The people running their company famously didn't have a single person who had ever worked in the hyper competitive grocery industry.

Theranos reminds me of that a little. The statements she makes sound like she doesn't know all that much about medicine or the clinical lab. The things she says sound like they are meant to appeal to people that don't know anything about lab testing.

She has her stuff patented. Now put it out there and let the medical world verify its legitimacy. If it is verified, Quest or LabCorp will buy her company out for many many billions.
 
yaah said:
Well I find it hard to believe they don't have any endgame. Can their plan really be to have this woman parade around to media outlets for fawning portrayals, then wait for $ to roll in? I don't think that many people would invest in BS. I suspect initial studies were promising and they had all kinds of projections showing what could happen with increasing business and such.

I mean, I can understand why older politicians and military types would be on the board. Easy paycheck. But who were/are all the investors? There can't have been that many people with significant lab experience investing $. Maybe that's part of the reason they are so pissed at Labcorp, maybe they offered labcorp part of the company.
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I actually *don't* understand why the political and military bigwigs would be on board. That is the biggest red flag that there's something else going on that the rest of us aren't privy to. Is Holmes' family connected or something? Is the real founder of the concept (whoever that might be, because I suspect Holmes is a hired talking head) connected?

I can't wait till the whole thing implodes so we can learn the truth while we toast marshmallows over the flaming embers of what remains.
 
pathdoc33 said:
I actually *don't* understand why the political and military bigwigs would be on board. That is the biggest red flag that there's something else going on that the rest of us aren't privy to. Is Holmes' family connected or something? Is the real founder of the concept (whoever that might be, because I suspect Holmes is a hired talking head) connected?

I can't wait till the whole thing implodes so we can learn the truth while we toast marshmallows over the flaming embers of what remains.
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Holmes' family is connected and her first money was provided by a former neighbor and family friend from a very big name tech VC firm.

One article I read said the reason there are so many military and political people on the board is because the company wanted to get exclusive rights to all military and VA testing. It's much easier to do when you have such big names on your board. Their goal was to require all testing to go through Theranos.
 
Theranos just isn't very interesting, in my opinion, and never really has been. Just one of many flash-in-the-pan Silicon Valley VC gambles.
 
PainDrain said:
Holmes' family is connected and her first money was provided by a former neighbor and family friend from a very big name tech VC firm.

One article I read said the reason there are so many military and political people on the board is because the company wanted to get exclusive rights to all military and VA testing. It's much easier to do when you have such big names on your board. Their goal was to require all testing to go through Theranos.
Click to expand...

The part about wanting exclusive rights to military testing is not surprising. It must have taken serious cash to get all those bigwigs on the board on the front end.
 
pathstudent said:
I don't know if any of you are old enough to remember the dot com boom of the late 90s, but there was a company called WebVan. They were an online grocery deliver service that went from being worth 100s of millions to zilch in a few short years. The people running their company famously didn't have a single person who had ever worked in the hyper competitive grocery industry.

Theranos reminds me of that a little. The statements she makes sound like she doesn't know all that much about medicine or the clinical lab. The things she says sound like they are meant to appeal to people that don't know anything about lab testing.

She has her stuff patented. Now put it out there and let the medical world verify its legitimacy. If it is verified, Quest or LabCorp will buy her company out for many many billions.
Click to expand...

My in-laws invested a significant amount of money (10 to 20k) in Webvan. They chose to do that over paying my husband's college tuition. Everyone advised them against it but they didn't listen. Because Webvan was as obvious a scam as Theranos. They had lots of hype and nothing to back it up. For some reason, people get all kinds of obsessed with the idea of "disruptive" technology.
 
I like disruptive technology for when it brings equities like Walmart cheap for an investor like me.

The theranos exec missed experiencing The Wizard of Oz. Obviously past generations had their own scam artists in times gone by and history never fails to repeat itself.

Never let a fool keep his money!
 
pathdoc33 said:
The part about wanting exclusive rights to military testing is not surprising. It must have taken serious cash to get all those bigwigs on the board on the front end.
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Yes - there are serious applications for low-cost, high-output portable analyzers that could be used at things like military bases. The bridge between POC and traditional lab testing. If that would be their niche, go for it. But I don't think I've seen any hint of that in any of their PR blitz or publicity.

They just seem really tone-deaf. They continue to deny that questions about running every test off of blood drops might be legitimate questions. Meanwhile AJCP just published a paper http://ajcp.oxfordjournals.org/content/144/6/885 about how values of common tests can fluctuate drop to drop.
 
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PainDrain said:
One article I read said the reason there are so many military and political people on the board is because the company wanted to get exclusive rights to all military and VA testing. It's much easier to do when you have such big names on your board. Their goal was to require all testing to go through Theranos.
Click to expand...

Ehh. Then the author of that article has no insight into the military. Military clinical labs are accredited by CAP just like civilian ones are. We have our own federal regulations that mirror CLIA'88 (CLIP). And it would be pretty tough for Theranos to get exclusive rights to DOD hospital labs when a. individual DOD hospital laboratories are authorized to execute their own contracts with vendors for clinical laboratory testing equipment and b. The DOD signed a multiyear contract for clinical laboratory reference testing with Labcorp just last year.

The day that I get a non-FDA approved instrument with no validating data foisted on me by the likes of Bill Frist, Henry Kissinger, and James Mattis is the day that I go straight to the New York Times, Washington Post, and Wall Street Journal. It would make the Walter Reed scandal look like the XYZ Affair in comparison.

Although, based on the WSJ article WEBB posted above, If I were a lab director at a community hospital in California, I might send all my testing to Theranos with the knowledge that the testing was being sent to UCSF and Theranos was subsidizing the difference between their ~$7 price tag for a CMP and UCSF's ~$300 price tag.

Walgreens will soon drop Theranos like Sanofi dropped Mannkind (biotech investing simile).
 
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How much longer can they afford to pay other labs to do the work, pay their own employees, invest in infrastructure etc? They have to be burning through cash.

Theranos was instrumental in getting the laws changed in Arizona for direct access testing. Quest responded by partnering with Safeway. Wonder if Quest is sorry about that now.
 
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