Theranos Continues Its Sparring Match With The Wall Street Journal

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Laboratory vendor newcomer Theranos has been a media darling since soon after its 19-year old founder dropped out of Stanford to launch the company. Claiming to have engineered a lab test analyzer that can produce accurate test results cheaper, faster, and with far less blood than any other analyzer currently available on the market, the company’s spectacular claims drew both excitement and skepticism from an industry that’s ripe for innovation, but that’s more accustomed to disappointment. Theranos fanned the fire of this skepticism by flatly refusing to release details about its new invention, specifically details that would convince doctors that results from the Theranos lab analyzer were as accurate as any other. Rather than meet these challenges to its technology directly, Theranos side-stepped the questions, citing a need to protect proprietary secrets and pointing concerned members of the clinical community to its recently acquired FDA clearance, which only investigates a blood test for Herpes, but which Theranos used as evidence that its testing process in general is safe and effective.

The back-and-fourth between Theranos and the clinical community came to a fevered pitch last week when Pulitzer Prize-winning investigative journalist John Carreyrou published a scathing story in the Wall Street Journal on Thursday claiming that the company grossly misrepresents the capabilities of its new lab analyzer, reporting that while its marketing material suggests it can be used for a wide variety of tests, the company only uses its own analyzer for 15 of the 240 different blood tests it performs, while the remainder are done by traditional lab analyzers. Even more alarming, Carreyrou reports that CMS sent Theranos a batch of samples to test as a means of validating its testing process. According to interviews with former employees, Theranos split the CMS samples and ran them through both their own analyzer and a traditional analyzer, coming up with significantly different results on some tests. Theranos then threw out its own analyzer’s results and sent CMS the results from the traditional analyzer instead.

Theranos responded to the allegations outlined in Carreyrou’s article the same morning that the article was published, arguing in a blog post that the story was “grounded in baseless assertions by inexperienced and disgruntled former employees,” and that the research team behind the story was given more than 1,000 pages of statements and documents that established the accuracy of each of its tests. The company also claims that it offered to send one of its analyzers to the WSJ office so they could see it first hand and compare its results to that of a traditional analyzer.

Carreyrou published a second piece about Theranos the very next day. In his second piece, he reports that Theranos received an unannounced visit from the FDA over the summer during which the company was told that the “nanotainers” they had been using to collect and process blood specimens with were in fact unapproved medical devices and should only be used to process the herpes test it had already received FDA clearance for. Since that visit, Carreyrou says Theranos has stopped using its own analyzers on any tests, other than the approved herpes test, meaning Theranos processes just one of the 240 tests it markets using its groundbreaking finger-stick technology. Walgreens, which provides blood draw services for Theranos, confirmed that the company recently suspended finger-prick blood draws across all of its Walgreens sites and is now processing tests exclusively with venous draws.

After this second, more damning, story was published, Theranos again responded. In its response, the company starts, “We are disappointed to see that The Wall Street Journal still can’t get its facts straight,” but then perplexingly goes on to acknowledge that its “nanotainers” are indeed being investigated by the FDA and that until the approval is secured, it will use traditional containers and venous blood draws for all of its tests. The statement from Theranos does not acknowledge the implied conclusion that this means it is also no longer using its own analyzer. 

In conclusion, last week the healthcare community learned that Theranos, the startup that has been pushing off skeptics and boasting about its revolutionary finger-stick lab tests, is no longer using finger sticks to collect samples and is running a traditional lab behind the scenes to process test results. The company does have proprietary finger-stick technology that it has succeeded in rolling out for herpes tests, which in and of itself is promising. It has plans to roll that technology out across many more tests in the coming years, but it will not offer any new tests through its analyzer until it receives FDA clearance for each component of its testing system and each of the tests that it offers, which could easily take a decade or more.


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