Theranos Scales Back to All But One of Its 'Finger Stick' Tests

Elizabeth Holmes of Theranos in an interview.  (Wikimedia Commons)

Update, 3.38 p.m. Oct 16: Theranos issued the following statement this afternoon. The company said the FDA is putting its Nanotainer tube, which it uses to collect blood samples, through a rigorous review process. The statement said the use of its Nanotainer has been cleared for one test for Herpes, and implied that the process would be straightforward:

Now we’re working with them on clearance of just the Nanotainer™ tubes across all tests. But it’s the same tube. We’ve already met their rigorous standards in our first submission on our systems, and we’ll continue to do so.

But attorney Bradley Merrill Thompson, who specializes in FDA law with the firm Becker Epstein & Green, said it won't necessarily be easy for Theranos to get the use of the Nanotainer approved for all of its tests.

"The chemistry of each test is slightly different," he explained. "And the type of blood impacts the test in different ways for different tests."

Update, 12:23 p.m. Oct. 16: An FDA spokeswoman says the agency does not have any information to share at this time. Theranos has not responded to a request for comment.

Update, 9 p.m. Oct. 15: A new report from The Wall Street Journal claims that Theranos has stopped selling all but one of its finger stick tests under pressure from federal regulators, citing an unnamed source. The source also said that federal regulators had shown up unannounced at Theranos' doorstep. Theranos' CEO spoke on CNBC's Mad Money to refute the Wall Street Journal's claims.

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Original Story:

The Wall Street Journal on Thursday delivered an unexpected, scathing report on Theranos, the diagnostics startup with its charismatic, young founder Elizabeth Holmes.

For those who aren't familiar with Theranos, the biotech burst onto the scene in 2014, with its bold claim that it could diagnose a variety of diseases with a finger stick that takes just a few drops of blood -- as opposed to a blood draw. Theranos quickly became a media sensation, with its CEO depicted as a young visionary in the pages of New Yorker, Forbes and Fortune.

But some scientists and health writers saw past the hype months ago. They took to their personal blogs and social media to ask some pertinent questions about the science behind Theranos' test, which largely went unanswered. Some requested that Theranos publish peer-reviewed studies to prove the validity of its test.

At health conferences and gatherings, I've heard similar skepticism about Theranos' science and its multi-billion dollar valuation, as well as increasing calls for proof to back up its claims. Theranos has sought FDA approval for its tests, but it has evaded questions about its technology. 

As Dr. David Koch, president of the American Association for Clinical Chemistry and a professor at Emory University told Business Insider in April: "It's impossible to comment on how good this is going to be — it may be wonderful and it may bomb, but I really can't be more definitive because there's nothing to really look at, to read, to react to." Theranos' blood test is available in select Walgreens, including in Palo Alto, Calif. and throughout Arizona.

WSJ did dig up some fresh criticisms in its report, primarily from unnamed former employees. Here are some of the key points from WSJ's piece, which is well worth a read:

  • Rather than hundreds of tests, the article claims that Theranos can only do fifteen on its Edison machines. Theranos responded that this is false, citing "trade secrets."
  • Doctors shared mixed views of Theranos' test. Some say it's convenient as the results arrive in 15 minutes. Others expressed that they couldn't trust the data.
  • Theranos doesn't need FDA approval, but it has sought it in order to be rigorous and transparent. But WSJ reporters say they reviewed "internal emails," which suggest that the results may be off. Also, a chart in the article showed how a Theranos blood test result vastly differed from a "hospital result." Theranos responded to say that these fluctuations are commonplace, and due to diet and other lifestyle choices.
  • A nurse and doctor interviewed by the WSJ reported abnormal test results after using Theranos' test.

In my view, Theranos' secretive approach is leaving it open to these kind of criticisms. While I appreciate the importance of trade secrets and intellectual property, Theranos says it did provide 1,000 pages of data to WSJ. How about sharing this with other media outlets and/or academics scientists, so they can form their own opinion about the test? And I'm not the only reporter who has expressed this view: 

As you might expect, Theranos wrote a rebuttal to the WSJ piece. Here's my summary of the key points:

  • Why didn't the Wall Street Journal publish over 1,000 pages of documents and evidence, rather than relying on disgruntled former employees?
  • Theranos' tests have proven accurate for tens of thousands of customers.
  • Theranos is working closely with the FDA to seek approval for its tests.
  • The sources that WSJ spoke to were not in a position to understand the technology and the science. WSJ declined an opportunity to try out the test for themselves.
  • Stories like these "come along when you threaten to change things."

I'm sympathetic to Holmes, particularly in her claim that innovators are often the subject of skepticism, but I for one would like to see greater transparency going forward.

As Matthew Herper from Forbes points out, an FDA approval doesn't answer all the questions a patient or health professional might have about the test. Moreover, Theranos did not make available its CEO to answer the WSJ's legitimate concerns. Let's hope this conversation will result in some much-needed answers.

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Editor's Note: An earlier version of this story stated that the FDA had ordered Theranos to stop selling all but one of its finger-stick tests. What the Wall Street Journal story said is that Theranos withdrew all but one of its finger-stick tests "under pressure from regulators."

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