Here's a nice profile from the New Yorker in late 2014:<p><a href="http://www.newyorker.com/magazine/2014/12/15/blood-simpler" rel="nofollow">http://www.newyorker.com/magazine/2014/12/15/blood-simpler</a><p>I mean "nice" as in, a good read...it's a flattering profile of Holmes -- she comes off well, as a genuinely passionate person, and even if she had stayed in school, it sounds like she would've still made a great impact.<p>But the article also raises concerns that seem to be corroborated by the OP:<p>> <i>Clarke argues that finger-stick blood tests aren’t reliable for clinical diagnostic tests; because the blood isn’t drawn from a vein, the sample can be contaminated by lanced capillaries or damaged tissue. Holmes strongly disagrees: “We have data that show you can get a perfect correlation between a finger stick and a venipuncture for every test that we run.” When I asked for evidence, I was sent a document by Daniel P. Edlin, Theranos’s senior product manager, titled “Select Data.” It purported to show favorable results from numerous comparison tests. I asked Edlin if the tests had been conducted by an independent third party. He replied by e-mail: “The clinical tests were conducted by a combination of Theranos and external labs,” but he wouldn’t say which ones.</i><p>Um, OK. I don't know much about this testing process...but...what trade secrets are being protected by hiding the methodology and source of the comparative test results?
Like many of us, Elizabeth Holmes is smart and had a good idea to change a large industry. Unlike many of us, she has managed to convince several billionaires to make her one too, based almost solely on the strength of her idea. I don't know how much money she has personally taken off the table during her funding rounds, but for her sake I hope it's enough to last her for the rest of her life.<p>I don't doubt that she is sincere in wanting to build this business and take over the blood testing industry. But Theranos is looking more and more like a cautionary tale about why VC's and angels shouldn't give any Stanford dropout with little more than an idea and a dream a multi-billion dollar fictional valuation and tens or hundreds of millions of dollars in real cash to burn in the streets.
> Mr. Balwani replied the next day, copying in Ms. Holmes. “I am extremely irritated and frustrated by folks with no legal background taking legal positions and interpretations on these matters,” he wrote. “This must stop.”<p>Wow. What a terrible response to get from company leadership. It should be completely appropriate for an employee to bring a concern to the attention of leadership based on a plain-English reading of a statute or regulation. Obviously, I don't know what kind of email the person sent, but if it was something like, "A plain English interpretation suggests that we are required to ... " then the right response is to thank them for bringing it to attention, and then engage people for an appropriate review. Every time I've dealt with a legal situation in a corporate environment, the plain English reading was ballpark a correct way to understand it, with occasionally some detailed nuances for which it was important to have legal input, but which did not radically change the situation. I've never run into a case where the required action was opposite than it seemed, or anything like that, although I'm sure surprising things come up from time to time.<p>I understand why they might ask people to stop discussing it, on a big company email list or something like that, but bringing it to the attention of the appropriate company leader, is exactly the right thing to do. Thank them and look into it.
A critical opinion piece on Theranos from the journal <i>Clinical Chemistry and Laboratory Medicine</i>:<p><a href="http://www.degruyter.com/view/j/cclm.2015.53.issue-7/cclm-2015-0356/cclm-2015-0356.xml" rel="nofollow">http://www.degruyter.com/view/j/cclm.2015.53.issue-7/cclm-20...</a>
I am genuinely confused by the overall thrust of the article.<p>1st Theme says: Theranos doesn't use Edison (thier in house testing device) & instead use regular equipment from companies like Siemens. This is a marketing problem because the company is saying its using one device but is actually using another one.<p>2nd theme: lab tests from Theranos differ from generally accepted standards. How do they differ if in fact they are using the same tests as everybody else? Is it just the general variability of lab results and similar variability could be find in quest diagnostics as well?<p>3rd Theme: almost all people say Theranos is dramatically cheaper than competitors. How is that possible when they are using the same equipment as everybody else for most of the tests? Is it a process innovation in operations rather than from Edison/better equipment tech? Or are they just subsidizing these costs and being cheaper and possible have bad unit economics?<p>The are two plausible storylines that can seem to reconcile these three themes is:<p>Storyline 1 (Negative)-
Theranos seem to be doing a process innovation rather than an underlying equipment innovation. That process innovation perhaps includes diluting blood samples 1) to meet thier marketing promise of taking less blood 2) somehow taking less blood and diluting the samples to meet the standard for traditional equipments AND still lead to cheaper operational costs that lead to lower prices. But - somehow these diluted blood samples show more than normal variability.<p>Storyline 2 (not so negative)
Traditional lab companies are ridiculously inefficient from an operations perspective. Theranos is able to take the same equipment as everybody else but because of thier operational efficiency make the end service dramatically cheaper. The variability in tests results is kind of standard in the lab testing market.<p>Am I thinking about this the right way or missing any big parts?
>>Theranos claims that the usual delay of testing in centralized laboratories is approximately 3 days and that they will generate and deliver their data much faster (e.g., within 4 h). The 3-day delay claim is not accurate. The bulk of laboratory testing in centralized laboratories is completed within an hour or two (calculated from time of sample collection to time of results posting for physician review). For example, in our laboratory, more than 90% of creatinine and troponin requests from all wards are completed in <1 h and more than 97% in <2 h. It is thus questionable that Theranos’s technology will be able to deliver faster results than the ones mentioned... Consequently, faster analysis will not have a major impact on patient outcomes.<p><a href="http://www.degruyter.com/view/j/cclm.2015.53.issue-7/cclm-2015-0356/cclm-2015-0356.xml" rel="nofollow">http://www.degruyter.com/view/j/cclm.2015.53.issue-7/cclm-20...</a><p>This is the same kind of bullshit I see in academia, where a new technology is promised to replace an old technology that works fine, but now they have a 9 billion dollar valuation!
Aside from whether their technology actually works or not, the central premise that cheaper, easier and more frequent testing will improve outcomes is unproven. There are many potential downsides. It might increase health spending through extra doctor visits, the need for repeat testing and more invasive and expensive investigations. But will it actually make anyone's life better? Bear in mind that even a single, obvious test performed in a high risk population to screen for say breast cancer or ovarian cancer, either barely moves the needle in saving lives or ends up being useless. What effect does Theranos think indiscriminate widespread testing will have?<p>With all these competing risks, this frequent testing strategy needs to be evaluated in randomised double blind clinical trials. Before that though, Theranos needs to submit their tests for independent validation in many thousands of patients, and publish the results.<p>I note this single study which compared Theranos' CRP to a conventional method [1]. The Pearson correlation was 0.85, which I don't think is really good enough.<p>[1] <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091290/" rel="nofollow">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091290/</a>
It's not necessarily bad business or bad practice to launch a company before the technology is ready, and to use a more conventional, cheaper substitute in the interim. I remember reading about a company that offered automated translation, but started out with human translators to validate the increased market size at the lowered price point. They used the validation to raise enough money to continue growing a user base at a per-unit-loss as well as develop the machine translation software to the point of marketability.
Getting blood from someone's finger will lead to incorrect results in many tests because other things diffuse into the blood. The things can lead to very inaccurate results. This is a BIG problem for Theranos.
Sounds like the accuracy testing should be blind but isn't. Why not?<p>It seems like disclosing that a sample is a test is more likely to negatively affect the accuracy of the test than improve it. The need for double blind trials is normally well understood. This is not an experiment, but as a test it seems like it would benefit from at least single blind: lab is unaware - accuracy tests are mixed randomly into the genuine population of testing requests. Kind of like how the TSA is occasionally tested by inspectors who bring all sorts of weapons through.
Seems only sporting to also include a link to their PR response to the WSJ article: <a href="https://www.theranos.com/news/posts/statement-from-theranos" rel="nofollow">https://www.theranos.com/news/posts/statement-from-theranos</a><p>Typical PR drivel. It's also a bit rich to complain about scientific inaccuracy, and boast of opening things up to the FDA, when the Theranos testing platform remains to be thoroughly investigated in the peer-reviewed literature.
Interesting article. While the article paints a bleak picture of company operations, one item that sticks out in favor of the Company is that "Walgreens says its partnership with Theranos has gone smoothly overall."<p>Seems like there would a lot more complaints considering the number of tests conducted, and that the relationship would have been soured/severed if the results were not living up to Walgreen's satisfaction.
Too bad if they are undergoing troubles as I'm really hopeful they become more widely available in California. I'm using WellnessFX [0] and InsideTracker [1], but they are expensive and draw too much blood (which could be a good thing, actually).<p>[0] <a href="https://wwws.wellnessfx.com/" rel="nofollow">https://wwws.wellnessfx.com/</a><p>[1] <a href="https://www.insidetracker.com/" rel="nofollow">https://www.insidetracker.com/</a>
Meh..<p>You can resell a test so long as you follow the rules of the contract of the manufacturer and applicable CLIA and other FDA regulations. These are subject to audit etc... You should not report clinical results from tests not run in a CLIA or FDA approved way. So if a test is run on Siemens for reporting clinical results then the audit goes on that pathway. Diluting the pinprick blood to run on a test that requires larger volumes probably won't work either unless they've shown it does and that of course depends on the CLIA and/or FDA regulations around the test to prove equivalence. It seems like it won't work since the tests have specific input requirements (e.g. 100mL plasma vs 1mL). You might be able to go the other way.. but you miss the cellular and interstitial components that may add noise (e.g. potassium which cells bioaccumulate etc)..<p>Which other rules apply probably depends on interpretation of whether these are lab developed tests or FDA regulated and this area may require clarification etc... which will depend test to test etc...<p>Otherwise it sounds like they may have calibration issues which are normal. Outliers happen all the time. If the technology doesn't have some fundamental limit of detection based on the sample volume then they just need to keep iterating. Or the components of blood from the pin prick differ significantly from blood taken from the vein. The data may just be noisy. What that noise level is matters in terms of the detection limits. It is probably too early to tell. Internally they will be tracking this and trying to figure it out.<p>So this article seems like click bait, but what do I know.
To bypass the paywall you can search for the title in Google, or click here: <a href="http://lmgtfy.com/?q=Hot+Startup+Theranos+Has+Struggled+With+Its+Blood-Test+Technology&l=1" rel="nofollow">http://lmgtfy.com/?q=Hot+Startup+Theranos+Has+Struggled+With...</a>
I believe parts are a scam and parts are good
The pathology diagnostics field is ripe for disruption with easy access and visible pricing and even if they do this well they will probably disrupt the big players. In terms of new technology I very much doubt they have anything substantial.
She'll be on CNBC tonight at 6<p><a href="https://twitter.com/MadMoneyOnCNBC/status/654674975798919168" rel="nofollow">https://twitter.com/MadMoneyOnCNBC/status/654674975798919168</a>
Sounds like this is a problem with the testing authorities as well. Instead of sending them full blood samples taken from veins by a trained nurse, they should have sent them finger pricks done at Walgreens.
Obligatory click-through-Google URL:<p><a href="https://www.google.com/search?q=Theranos+Has+Struggled+With+Blood+Tests" rel="nofollow">https://www.google.com/search?q=Theranos+Has+Struggled+With+...</a><p>edit:<p>I had known about Theranos mostly for being a highly valued startup by a young college dropout involving something in the medical field...I assumed it was more related to the scientific research side...but in the article it says it's been offering tests to the public since 2013 (and that that appears to be the main potential source of revenue)...has anyone's doctor suggested the tests to them? It looks like they have a couple testing centers in Palo Alto but my general physician has never mentioned the option to me.
Side note: Did anyone else find the writing for this article absolutely horrendous?<p><pre><code> “They were never able to produce them,” she says.
Ms. King says the company did show detailed
testing-accuracy data to the nurse.
</code></pre>
I would have flunked freshman-english if I wrote papers like this. There was zero effort to link thoughts together all-throughout the piece. I thought the point of a pay-wall was to promote and support <i>good</i> content?
No fan of this bizarre Illuminati-backed startup, but this article reads like a well funded hedge fund hit piece. Maybe some players shorting OTC contracts on their stock? The biotech industry is heavily manipulated so if they're facing this kind of opposition, maybe it really does make sense to have guys like Henry Kissinger on the board ...