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"In a June 2014 cover story for Fortune, I helped raise to prominence the inventor-entrepreneur Elizabeth Holmes and her remarkable\u2014I think everyone will still go along with that adjective\u2014diagnostics company Theranos.\nFairly high up in my story there is a whopping false statement. After explaining that Theranos\u2019s tests could be performed with a finger-stick, rather than using traditional venipuncture (a syringe in the crook of the arm), I wrote that the company \u201Ccurrently offers 200\u2014and is ramping up to offer more than 1000\u2014of the most commonly ordered blood diagnostic tests, all without the need of a syringe.\u201D\nSixteen months later, John Carreyrou of the Wall Street Journal published a now famous front-page story containing a wide range of unflattering accusations about Theranos. Among them, he reported that one \u201Cformer senior employee\u201D had told him\u2014in an account generally corroborated by three other former employees\u2014that as of December 2014, the company was actually performing only about 15 finger-stick tests using its proprietary technology; the remainder were being performed using conventional, third-party analyzer machines, made by companies like Siemens\u2014i.e., the same machines used by conventional labs like Quest Diagnostics \n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\tDGX\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t and LabCorp \n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\tLH\n\t\t\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\n\t\t\t.\nIn that Journal article, a Theranos spokesperson was quoted flatly denying the newspaper\u2019s allegations in a blanket manner, but refusing to be specific, citing trade secrets. Notably, from my perspective, she did not say how many tests the company had, in fact, been performing by proprietary methods in December 2014.\nIn a longer statement issued the same day on its website, Theranos further blasted the Journal for, among other things, relying on the accounts of \u201Canonymous, disgruntled former employees,\u201D but still declined to state how many proprietary tests it had really been performing.\nIt wasn\u2019t until a week later\u2014on Oct. 22\u2014that Theranos, after stonewalling and threats of legal action failed to quell the furor, offered a serious, 14-page response to the Journal article, addressing the full panoply of its accusations. Among other things the company asserted that, as of December 2014, it had in fact been performing \u201Cmore than 80 of the tests on our online test menu via finger-stick,\u201D and that all but \u201Ca few\u201D of those \u201Cran using proprietary technologies.\u201D It also asserted that in the fourth quarter of 2014, 57% of all tests ordered had been performed by finger-stick.\nThose figures, if accurate, would suggest that the company might well be accomplishing, as it has claimed, something genuinely innovative and beneficial to society. I should add that the company\u2019s extremely low prices and price-transparency would also be of unquestionable benefit to society, even if the company weren\u2019t doing anything technologically innovative. On the other hand, all these advances matter only if Theranos\u2019s tests are also reliable, which the Journal article also cast doubt upon. In my opinion, the evidence for this was weaker than its evidence that the company was misrepresenting its accomplishments.\nAfter Theranos\u2019s Oct. 22 statement, I contacted officials there to inquire how many tests it had actually been commercially performing by proprietary means in June 2014, when I had reported that it was offering more than 200. A spokesperson acknowledged to me that it was fewer than 200, but declined to specify how many. She said she\u2019d send a statement.\n\n\t\t\t\t\n\t\t\t\n\t\t\t\nThe company&amp;#8217;s statement arrived Nov. 3. \u201CAs discussed when you visited Theranos,\u201D it said, \u201CTheranos could perform hundreds of tests (more than 200) using its proprietary technologies. The reports you reviewed at Theranos covered many of those tests Theranos developed for use with finger-stick samples.\u201D\n(The company had, indeed, provided me in the Spring of 2014 with what it said were\u2014and what looked to be\u2014validation studies for scores of different diagnostic tests, though, in truth, I lacked the expertise to assess their significance.)\nThe statement then went on to address my followup question, which was basically: If you were capable of doing 200-plus tests using your proprietary methods, why weren\u2019t you in fact doing them?\nHere, with trademark, Theranos-ian opacity, is the reply:\nOver time, we&amp;#8217;ve been optimizing our clinical lab to bring up tests that are more commonly ordered, and in some cases move resources off the proprietary tests that are less commonly ordered to get to a point where the ordering patterns we are seeing can all be accommodated through our finger-stick technology.\nGot that? \nI then started looking back at my research for the original story\u2014which had been conducted, by then, 17-19 months earlier\u2014to try to reconstruct how I made the error.\nAs much as I\u2019d like to say that Holmes lied to me, I don\u2019t think she did. I do believe I was misled\u2014intentionally\u2014but I was also culpable, in that I failed to probe certain exasperatingly opaque answers that I repeatedly received.\n\u201CWe do routine, specialty, and esoteric tests,\u201D Holmes told me in May 2014. \u201CWhat we\u2019ve done is take those, and develop the chemistry and analytic systems that made it possible to run them on a microsystem.\u201D\nWhen I started my research in March 2014, there were maybe something like 100 tests listed on Theranos\u2019s online test menu. The number was gradually climbing as my work continued. By the time I was ready to publish there were 214 tests listed. I assumed that meant they had now adapted 214 tests to run on their microsystem.\nIn fact, at the time I didn\u2019t know what else it could have meant. That\u2019s because, so far as I can tell, at the time of my research the company had never revealed that it ever used conventional, nonproprietary analyzers to perform the tests it listed on its menu other than for research purposes.\nAbout a year later\u2014in May 2015\u2014Holmes did explain to me, as I reported then, that the company had begun using such third-party analyzers, analyzing blood drawn by venipuncture. It had begun doing so, she explained, in order to be able to perform less commonly ordered tests, which she referred to as \u201Cesoteric\u201D tests, thereby providing customers with one-stop shopping. This was presented to me as a new development, however\u2014a departure from prior practice.\nIn mid-September 2015\u2014after an inspection at which an FDA official opined that the company\u2019s tiny blood collection device, known as a nanotainer, was an \u201Cuncleared\u201D medical device\u2014Theranos discontinued using its proprietary methods for all but at most one test, for which it had already received full FDA approval. This fact didn\u2019t come to light until a month later, about a day after Carreyrou\u2019s first article, and just a few hours before his second.\nBack in early 2014, on both its website and in press releases of that time, Theranos did disclose that \u201Cwe can use a tiny finger-stick or collect a micro-sample from a venous draw\u201D (emphasis added). It thereby acknowledged that it was capable of doing venipuncture, but stressed that even then it strived to take only micro-samples. In our conversations, Holmes defined the word &amp;#8220;micro-sample&amp;#8221; as referring to the &amp;#8220;tiny samples&amp;#8221; or &amp;#8220;these tiny droplets we take.&amp;#8221;\nThus, \u201Cmicro-samples\u201D\u2014whether from finger-stick or venipuncture\u2014were what the company was about, and my assumption was that in either case they were being analyzed by the same proprietary devices, which were designed specifically to read tiny samples.\nThe company\u2019s ads, promotional materials, and posters hanging on the headquarter walls, all seemed to hammer home this point. They featured slogans like \u201COne tiny drop changes everything\u201D; \u201CAll the same tests. One tiny sample\u201D; and \u201C1/1000th the size of a typical blood draw; Theranos runs any test available in central laboratories.\u201D\nMy interviews with Holmes in 2014 seemed to further reenforce the point. \u201CWhen we do collect venipuncture,\u201D Holmes explained to me back then, \u201Cwe take a smaller sample than traditionally required and we also use the smallest needle. It\u2019s a tiny butterfly needle. The least painful. So it is a smaller volume.\u201D\nSurely this meant they were still analyzing these tiny draws with their proprietary devices\u2014the ones uniquely designed to do so, I thought.\nNevertheless, the truth is that there was at least one great, flapping red flag that I missed. By May of 2014, I had already heard about anecdotes in which people had shown up at one of Theranos\u2019s Wellness Centers and had been disappointed to learn that the test they ordered would require a venipuncture draw.\nSo I asked why that sometimes happened.\n\u201CThe biggest reason,\u201D Holmes told me in May 2014, \u201Cis we\u2019re scaling. As we\u2019re building out this infrastructure, we\u2019re also building out our inventory and our capacity in terms of the number of samples that we can handle at any given point in time. . . . We\u2019ll use venipuncture in addition to the micro-samples just to handle the volume of sample that we\u2019re processing.\u201D\nI couldn\u2019t understand why venipuncture would help cope with volume. Were they running out of nanotainers or some other specialized piece of equipment needed for fingerstick draws at some of the Wellness Centers? Running short of some reagent? Or was it just that they hadn\u2019t yet adapted certain tests for their proprietary platform?\n\u201CIt\u2019s more how we configure our own analytical systems,\u201D she said, \u201Cand the capacity that we have in those systems at any given point in time. And it evolves and it\u2019s changing. Every week we have more and more capacity.\u201D\nI remember coming back to this point again later: How exactly would venipuncture help them cope with volume?\nI was told that my question was getting into the realm of trade secret.\nA secret, for sure. But maybe a different kind of secret.\nSo I blew it. And I should have included all these colloquies in the original story. I regret the error."^^<http://www.w3.org/2001/XMLSchema#string>
<http://fortune.com/2015/12/17/how-theranos-misled-me-elizabeth-holmes/>