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Elizabeth Holmes Finally Releases Theranos Data, Including A 'miniLab' (cnbc.com)

Posted by BeauHD on from the blood-from-veins-not-fingers dept.

An anonymous reader quotes a report from CNBC: Theranos CEO Elizabeth Holmes Monday outlined the steps she will take to increase transparency regarding the efficacy of the company's testing methods. Speaking at the conference of the American Association for Clinical Chemistry, Holmes said that Theranos will partner with other institutions "to validate and publish our results." And Holmes' planned presentation includes research conducted under Institutional Review Board-approved protocols. The company also said it intends to submit its results to a publication for peer-review. Holmes' presentation includes a slate of new products such as its miniLab, a robot that can process samples that normally require manual processing in traditional protocols. Theranos seems to be going back to the research and development drawing board, focusing on these new products instead of its much-debated small-volume blood collection technology. Theranos' miniLab is a self-contained laboratory that allows a robot to run a number of tests on samples. The miniLab contains different modules that allow it to conduct a series of tasks that traditionally would require multiple, separate machines. Theranos used its miniLab to run its Zika nucleic acid-amplification-based assay using finger-prick samples the company collected, some in the Dominican Republic. The samples were shipped back to Palo Alto, California, for analysis. Holmes said the results "demonstrate the miniLab's ability to perform automated, integrated molecular testing comparable to methods that require highly-trained personnel."

40 comments

  1. Holmes by fluffernutter · · Score: 4, Insightful

    I thought she was sidelined for 2 years? Seriously, what blessed lives these people lead to be taken seriously after screwing up so terribly. If I messed up half that bad at my job I'd be out on the street.

    --
    Laws are rules for the court, but merely a bottom bar to hit for life. Think beyond laws in your actions always.
    1. Re:Holmes by NotInHere · · Score: 2, Funny

      Its called "silicon valley". Failure is considered something good there. If you fail, you learn how to build a bigger and better unicorn.

    2. Re:Holmes by Anonymous Coward · · Score: 0

      If you think that's confined to Silicon Valley, you must not get around much.

      http://www.forbes.com/sites/su...

    3. Re:Holmes by Anonymous Coward · · Score: 0

      She's also involved in a congressional investigation, and I doubt the Silicon Valley reality distortion field extends that far.

    4. Re:Holmes by Anonymous Coward · · Score: 0

      She personally is not allowed to own or operate a lab for 2 years. However, she controls over 51% of Theranos. So in response to the ban, Theranos is shutting down their lab.

      The ban goes into effect in September, so she's still allowed to be there, and Theranos can (and likely will) issue an appeal to keep her in place, but the appeals almost always lose.

      Which is interesting, because how are they going to make money if they shut down the lab? Likely building boxes and trying to sell them to clinical labs as a tool manufacturer.

    5. Re:Holmes by ArmoredDragon · · Score: 3, Informative

      Its called "silicon valley". Failure is considered something good there. If you fail, you learn how to build a bigger and better unicorn.

      Every successful person has had some big failures before they succeeded, and for every successful company there are multiple failed ones. It's neither good nor bad, it's just life.

      As for Theranos...Well, let's just say that I work for one of their competitors, and what I know about this business is that there are routine audits by the FDA to send your lab a test sample, and you have to report back what you found in it given the test parameters that they gave to you. When given one of these samples, you can't speak to other labs about them or do anything that might give you any kind of hint of what the lab result should be, and you report back the findings just like you would with a regular patient lab specimen. If it doesn't fall within a specified range the FDA will notify you and you'll probably have to re-calibrate your equipment, and if it's way out of range then you'll probably get fined somewhere in the hundreds of millions of dollars.

      Or something to that effect. I work in the lab's IT department so I don't know the exact process.

      My question is: Did the FDA properly audit Theranos, and if not, why? From what I understand, this wasn't found out until some doctor saw his patient's results and questioned it, and then it got blown wide open from there. It shouldn't have even made it to that point really.

    6. Re:Holmes by slew · · Score: 4, Informative

      My question is: Did the FDA properly audit Theranos, and if not, why? From what I understand, this wasn't found out until some doctor saw his patient's results and questioned it, and then it got blown wide open from there. It shouldn't have even made it to that point really.

      As I understand it, the FDA *did* audit Theranos on a single test (HSV-1 IgG aka herpes test). That only tests for the presence (or absence) of antibodies, not a test that requires determining a reasonably accurate concentration of certain chemicals in blood so in a sense it was a somewhat easy test.

      Unfortunately, Theranos used the aura of this single approval to build their lab business which they apparently used their proprietary "nanotainer" collection tube. Regardless of the ultimate accuracy of their "Edison" machine used to gain their singular test approval (nobody knows outside the company how many samples were tested on Edison vs diluted and tested on standard lab equipment in production which is another FDA complaint that they didn't track this), the collection procedure also has to be FDA approved to assure audit-able quality and repeatably. This is where Theranos failed big time.

      Not only was the "nanotainer" not approved to be listed as collection device, but FDA audits revealed all sorts of problems with its quality control, including no supplier auditing, no validation procedures, nobody in the company approved the final design specifications before manufacturing commenced, no clear customer and lab complaint logging and handling procedure, etc, etc...As the FDA audited the complaint handling procedures it discovered complaint that involved the failure or accuracy of the device that were received and not logged as required (to establish a validation history of a procedure) which brings in to question the reliability of the tests results in actual field conditions.

    7. Re:Holmes by interkin3tic · · Score: 1

      I'm guessing there's plenty of wiggle room, though IANAL and I've never heard of the certification they revoked.

      I'm guessing, for example, that if they ACTUALLY came up with something that works, you'd find the certification reinstated. They have a lot of high powered investors who can pull some strings.

      And while it was based on snake oil, I'm still impressed with Holmes' ability to sell it. If anything, that's MORE impressive! She must have some amazing salesman skills. As well as zero ethics. Don't get me wrong, she very much should be out of a job and in jail, and I wouldn't be surprised if that were coming, but still, she has some talent, clearly.

    8. Re:Holmes by Aighearach · · Score: 1

      I thought she was sidelined for 2 years? Seriously, what blessed lives these people lead to be taken seriously after screwing up so terribly. If I messed up half that bad at my job I'd be out on the street.

      Yes, but it didn't start yet and will be on hold if she appeals. The company so far hasn't admitted that it has to shut the Arizona lab unless she resigns or appeals. She controls the company, so at this point she can steer it in for any sort of crash vector she wants.

      Interestingly, other media are not reporting this the way slashdot is, with her having finally released the data people want. Ars is running it as, she didn't release the data at all, she just launched a new product instead and left everybody scratching their heads. The new product isn't anything new, either, it competes with a lot of similar products from established companies.

    9. Re:Holmes by Anonymous Coward · · Score: 0

      It's called "woman in science" or often just "woman".

      They can do no wrong. Anything that was wrong was a man's fault. If they can't blame it on a man directly, then it was because she had to struggle SO HARD against the patriarchy and crossed a line.

    10. Re:Holmes by Anonymous Coward · · Score: 0

      ... there are routine audits by the FDA ...

      Given the horror stories told about forensic labs, I'm guessing such labs are not audited by anybody. It seems Theranos missed a golden opportunity there. In fact, most forensics isn't Science anyway, so there'd be little to audit. Something to ponder if one is ever arrested.

    11. Re:Holmes by Anonymous Coward · · Score: 0

      Every successful person has had some big failures before they succeeded, and for every successful company there are multiple failed ones. It's neither good nor bad, it's just life.

      Meanwhile, the people without the connections to try until they stop breaking shit (or more typically, until they hire people that tell them to fuck off and enjoy the money while not breaking shit) never get the chance to make the attempt.

    12. Re:Holmes by ArmoredDragon · · Score: 1

      Meanwhile, the people without the connections to try until they stop breaking shit (or more typically, until they hire people that tell them to fuck off and enjoy the money while not breaking shit) never get the chance to make the attempt.

      If you need more bridges, then simply create new ones. Lots of founders of big companies did exactly that from basically nothing.

  2. Believe it when you see it. by Anonymous Coward · · Score: 0

    The results, that is. Not just the smoke that's clouded Theranos since its inception.

  3. Witch doctors only provide evidence when troubled? by Anonymous Coward · · Score: 0

    If this was real medical testing , there would not be some "we will let you see now" shit.

  4. Desperate to keep the scam going by smooth+wombat · · Score: 4, Insightful

    While the article briefly mentions it, it is fascinating to note the process she has been claiming for years to be reliable, fast and needing only a prick of blood has been left out of the mix.

    Nope, she's not going to go down that route and open up the scam she's been running, instead deflecting by pointing out, "Shiny!", never mind all that other stuff she's been lying about.

    I wonder how many more investors will continue to pour their money down the black hole this women continues to more deeply dig.

    --
    We will bankrupt ourselves in the vain search for absolute security. -- Dwight D. Eisenhower
    1. Re:Desperate to keep the scam going by Anonymous Coward · · Score: 0

      "Zika is trending. Can we use that?"

  5. No jail? by Anonymous Coward · · Score: 0

    This woman has been unmasked as a large scale scammer. Does this is mean that, if the scale is large enough, jail is not an option?

    1. Re:No jail? by Anonymous Coward · · Score: 1

      No, jail is no option because she is a woman. If men get into prison, then its because they either raped women or because they were about to. But if women get into prison this is rape itself, because women get raped in prison. Therefore all feminists must fight for any accusations made against any woman because otherwise yet another woman will get to prison and will be raped.

    2. Re:No jail? by haruchai · · Score: 1

      "No, jail is no option because she is a woman"

      Don't tell Martha Stewart that; she'll be pissed she had to be federally raped for 6 months

      --
      Pain is merely failure leaving the body
    3. Re:No jail? by Anonymous Coward · · Score: 0

      If that's federal rape by the standards of an extremely wealthy white female stock fraudster, there have been millions of prisoners around the world who would be happy to demonstrate what federal rape *really* means.

  6. that ship sailed... by supernova87a · · Score: 3, Insightful

    Is this an absolute fucking joke??

    The ship for "transparency" sailed about 6 months ago, before the mass media fully exposed her and Theranos as being outright frauds as individuals and as a technology company. The moment is gone, pack it up Elizabeth....

    Anyone interested in what the "new Theranos" is should approach it as if it were a brand new company, with little/no track record and in the very early R&D phase. Perhaps with even more caution than that, if only to protect themselves from their historical baggage, and if not then at least to penalize socially irresponsible corporate practices.

    1. Re:that ship sailed... by Zontar_Thing_From_Ve · · Score: 1

      Anyone interested in what the "new Theranos" is should approach it as if it were a brand new company, with little/no track record and in the very early R&D phase. Perhaps with even more caution than that, if only to protect themselves from their historical baggage, and if not then at least to penalize socially irresponsible corporate practices.

      Investors are often stupid. You might remember how SCO's stock value was propped up for years by nothing but the hope by ignorant investors that they might actually win their case and hit the jackpot. This happened for quite a long time after it was clear to any IT person or legal person who wasn't involved in the case that SCO wasn't going to win. So it wouldn't surprise me at all if there are people out there who want to dump money in Theranos despite their past history.

  7. Elizabeth Holmes Finally Releases Theranos Data??? by whoever57 · · Score: 4, Informative

    No, there was no data released. Just a promise to release it, along with a new product announcement.

    Yes, the company did say that it would release data at the conference, but this did not happen.

    --
    The real "Libtards" are the Libertarians!
  8. Journalism ... or Lack Thereof by speedplane · · Score: 3, Insightful

    The reason why frauds like this persist has more to do with the media pushing the company's success story than the founders themselves. In the video attached to the article, you can see reporter Meg Tirrell bending over backwards to find the silver lining for Therenos. A little bit more realism and expertise in journalism would go a long way to preventing this harmful hype.

    --
    Fast Federal Court and I.T.C. updates
  9. Going with Plan B by Anonymous Coward · · Score: 1

    Sounds like the "minilab" is their back up plan.

    Who was it that said, "The minute you have a back up plan, you’ve admitted you’re not going to succeed.”

  10. Turd in the punch bowl by Anonymous Coward · · Score: 0

    I run tech in labs and my wife is an inspector. Since Theranos, states are much more rigorous on checking labs for problems. Good for consumers but a pain for the labs. Yeah, I'm bitter. My wife is super busy and I have coworkers freaking out. Theranos is a turd in the punch bowl.

  11. Medical establishment vs low cost options by justcauseisjustthat · · Score: 0

    I've got a bucket of popcorn and I'm cheering on Theranos because it's only companies like this that are going to shake up the current medical pricing model. I think it's stupid that they screwed up so badly on the first round, but I'm still hoping they can turn it around.

    1. Re:Medical establishment vs low cost options by Anonymous Coward · · Score: 2, Informative

      Uh, the reason why the competitive tests like Quest and LH cost more is because they actually work. Theranos is an outright fraud that was designed from the start to bilk clueless biotech generalist funds out of their cash.

      Moron.

    2. Re:Medical establishment vs low cost options by Applehu+Akbar · · Score: 0

      "it's only companies like this that are going to shake up the current medical pricing model."

      I suspect that this is the basis for much of the dudgeon directed against the idea of Silicon Valley "intruding" into the sacred medical field.

    3. Re:Medical establishment vs low cost options by justcauseisjustthat · · Score: 1

      Moron, wow, your narrow assumption then is that no new technology will ever be created that will be cheaper, more effective and more efficient , you do realize you are on a tech site?

    4. Re: Medical establishment vs low cost options by Anonymous Coward · · Score: 0

      No, you idiot. Scams do not turn around into valid businesses. I'm sure theranos would welcome new investors. Put your money where your mouth is. If there is better tech, then great. Just go through the same testing as standard land currently do. Bypassing that will save money, sure. But the point of medicine is reliability and reproducibility. It's not like silicon valley.

    5. Re: Medical establishment vs low cost options by justcauseisjustthat · · Score: 1

      "It's not like silicon valley." and that's why it's slow and takes decades if not centuries to develop and release anything new. Theranos was FDA approved, it didn't just pop up and start doing things, they went through there same hoops just with a large number of Washington insiders pushing it.
      Keep posting and hiding behind Anonymous Coward.... It shows nothing beyond a 110.

    6. Re: Medical establishment vs low cost options by Anonymous Coward · · Score: 0

      Theranos passed an FDA audit on a single, very easy herpes test. They then used this "FDA-audited" label to whitewash their entire lab business, that was largely not FDA-auditited, and where the FDA actually did look at things they voiced massive complaints about them.

    7. Re: Medical establishment vs low cost options by Anonymous Coward · · Score: 0

      "It's not like silicon valley." and that's why it's slow and takes decades if not centuries to develop and release anything new. Theranos was FDA approved, it didn't just pop up and start doing things, they went through there same hoops just with a large number of Washington insiders pushing it.
        Keep posting and hiding behind Anonymous Coward.... It shows nothing beyond a 110.

      Buddy, you are listening too much to the hype.

      http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm

      "The FDA does not approve companies." They inspect companies to ensure they follow either GMP (Good Manufacturing Practices) or GLP (Good Lab Practices) and Theranos was deficient under GLP in every single case and did not address the 45 concerns the FDA brought regarding their lab.

      https://techcrunch.com/2015/12/21/theranos-only-fda-approved-test-is-also-under-scrutiny-after-ex-employee-complaint/

      Theranos' one Herpes test was not FDA approved. It was registered under a regulation known as a Lab Developed Test, or LDT, which does not undergo a clinical trial at all. Instead, it says that if your lab follows GLP (which Theranos did not) and you believe a new test developed in your lab has value, you can register it as an LDT, but the FDA does not check the efficacy of the test at all. The LDT regs were built for a very specific reason, mostly so therapeutics manufacturers can run simple tests to identify and segregate patients into groups that may benefit from their drug or not, but has been so badly abused by companies like Theranos selling snake oil that they are up-regulating this model to the point that it's nearly impossible to do an LDT. And, the LDT clearance was pulled when Theranos failed to pass GLP.

      New things come out in medicine all the time. Most in Life Science do not hype their products or breakthroughs because the FDA has very specific rules against this, and because what people are doing is so scientifically complex that hype like this has a potential to create confusion amongst the general populace who is generally uneducated about the scientific complexities of medicine but are quite afraid of being sick and will pay a lot of money for snake oil with no way to be an informed purchaser. But there are great technologies coming out in just the last few years, such as cell imaging systems and liquid biopsies, DNA sequencing tests and stem cell therapies. These all played by the rules; Theranos' woes come from the fact that they chose to defy the rules and operate on hype hoping that would carry them. THey are not revolutionary in the slightest.

    8. Re: Medical establishment vs low cost options by Anonymous Coward · · Score: 0

      "It's not like silicon valley." and that's why it's slow and takes decades if not centuries to develop and release anything new. Theranos was FDA approved, it didn't just pop up and start doing things, they went through there same hoops just with a large number of Washington insiders pushing it.
        Keep posting and hiding behind Anonymous Coward.... It shows nothing beyond a 110.

      You are right. Invest in Theranos. They need the money, and are probably going to make a great turn around. Come on. You know it's a good deal.

    9. Re:Medical establishment vs low cost options by Anonymous Coward · · Score: 0

      or the fact it was a fraud and their tests did not work?

      the fact that non-functioning frauds are acceptable, in siliCON valley doesn't mean theyre a good thing you know.

  12. Science vs pseudoscience by John+Allsup · · Score: 1

    Faced with a theory and some evidence apparently supporting it, the questions me must ask are:

    1) What serious attempts have been made to find counter-evidence for this theory?
    2) How thorough have you been in listing things which could make your theory false?
    3) What sort of counter-evidence would disprove your theory?
    4) What assumptions are you depending upon when reasoning from empirical data to conclusions?

    If people are still playing the 'here is proof it works' game, what they are doing is probably not scientific.

    If a company or research group has not done the above, at best they have an early investigation into an area and a few educated guesses as to what is going on (and only then if they make it clear that this is the case). If they have not made serious attempts to disprove their theories, and have not made clear the limitations of their current understanding, and are passing off what they are doing as scientific, it is pseudoscientific. Simple as that. Science depends on a brutal honesty rooted in the desire to prove yourself wrong whenever you can, and to be clear what you have tried, what you could have tried, what you have not tried, and how you think others could demolish the theory you are putting forward. That brutal, ego-destroying attitude is central to proper science (see Feynman's Cargo Cult Science talk for a good exposition on this for a general audience).

    The trouble is, that in many areas, if one removes all the 'science that is not science', there's not a whole lot left.

    --
    John_Chalisque
  13. why is this relevant..??? by Anonymous Coward · · Score: 0

    Shes a fucked up individual whom got caught being stupid..
    im not chauvinistic, right person for the right job. But it seems that those whom try to make a statement
    (carly fiorina, Melissa mayer, Meg whittmen, etc) you all fall flat on ur faces trying to point out that your all successful women (maybe not so much meg).
    it seems these people want to make a statement about being successful woman. But to what expense? Theranos was about to push a tech to the market at the expense of peoples lives, accuracy, honesty and integrity. With statements like "if u have to think of a plan "b" then you have lost the battle" so fucking arrogent and backward "trump" thinking.
    so I ask again, why is this person still relevant? Better yet, why is she and her company still practicing? Wasnt she banned from all lab work? Wait wasn't she legealy banned from stepping into ANY LAB?

    should this be jail time for her??