Blood is drawn: Theranos responds vigorously to TTA re WSJ

From his very first interactions with Theranos, the reporter made abundantly clear that he considered Theranos to be a target to be taken down, and not simply the subject of an objective news story. The articles that appeared last week are the inevitable product of that approach.–Theranos Facts, 22 Oct

Breaking news. Blood is drawn. A spokesperson for Theranos (from FTI Consulting), Ms Shea Maney, has responded directly to this Editor regarding the content of the Wall Street Journal article, previously covered here (The $9 billion question mark) along with followup in primarily Fortune but also commentary in the Health Care Blog. Her note to me (which undoubtedly has gone to other press) is reprinted below in its entirety, save the standard closing line:

We read your coverage of Theranos with interest, and noticed you were particularly interested in accuracy and our finger-stick tests, among other themes. There have been a lot of inaccuracies in the coverage of these topics, which is why we have posted detailed information on our technology, accuracy, and conversations with The Wall Street Journal on our website:

On accuracy: Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve. We are confident in the reliability of our tests, because we have validated their accuracy.On the finger-stick test: Just this past July, FDA cleared Theranos’ finger-stick test for HSV-1 using our Nanotainer™ tubes, which included a rigorous review of our underlying test systems and finger-stick technology. In order to clear that technology, FDA rigorously reviewed our test systems and Nanotainer™ tubes and proprietary devices. Theranos provided study data from 818 subjects of varying age and ethnicity, demonstrating that our devices could be run accurately using only a finger-stick as well as a traditional venous draw across large numbers of Theranos devices, all compared against an FDA-cleared, commercially available reference method.

Without going into the weeds here–lab testing is very much outside our key coverage of telehealth and telecare related issues–we will leave it to others far more technically knowledgeable to test for the truth. But there are lessons to be learned here for any healthcare technology company. Familiar is go-to-market bumpiness in concordance with a company’s USP: in this case, offering tests, even highly specialized ones, as one-stop shopping at lower prices and with less blood drawn. Another familiar factor: going from a startup developing novel technologies in test to being FDA cleared for a broader market. They explain: “Because Theranos has been working to transition to an FDA framework, we have moved from use of our laboratory-developed tests (LDTs) to FDA-cleared and approved assays. At the same time, Theranos has been increasing the number of tests we offer, in order to become a full-service lab.”

FDA requirements alone are a mountain of work, but it’s part of the landscape. This is a company with hundreds of millions in ‘bets’ on it, a lot of moving parts, and moving fast. Those involved will differ in what happened (the Rashomon effect), especially those departed.

There appears to be a real fact gap in the WSJ article on the number of proprietary devices Theranos uses in its proprietary testing. This Editor was left with the impression from the WSJ article that ‘Edison’ was the sole device. The Theranos website takes some care in dispelling this. However more detail would have been appreciated.

What is most important is that this is clarified and that both regulators and the public are assured that Theranos is offering safe, accurate lab testing. If the WSJ reporter got it wrong, then there should be every effort made to get it right. (This is a forum of news and editorial opinion–this Editor has clarified a few since 2009, and freely published responses to let our Readers decide.) We know that competition will slam, like dogs will bark. We know that you can parse forever what appeared on a website when.

From a communications standpoint, Theranos has replied in a model fashion and quickly (WSJ was 10/15, this response is 10/22), one that those in our industry should take notes on.

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