By Allison Proffitt
October 22, 2015 | True to her word yesterday, Elizabeth Holmes’ company, Theranos, has released a 16-page rebuttal to the Wall Street Journal article published last week.
Holmes took the stage yesterday at the WSJDlive event and took questions from Wall Street Journal global technology editor Jonathan Krim. On stage Holmes was calm and collected, but for the most part she dodged questions. She focused on Theranos’ “transition” from a CLIA-certified lab offering laboratory developed tests to offering FDA compliant tests.
Theranos is secretive and the company has made no effort to clarify its science. Thus the terms “technology” and “devices” are vague placeholders that we all use for whatever it is that Theranos is doing to arrive at its results.
When Krim asked Holmes to confirm that she was only using proprietary technology to test for HSV-1, she immediately answered that the assertion was untrue. When he clarified to ask if the company was using the nanotainers for any other test she answered, “The nanotainers, you said technology initially,” before agreeing that the company had suspended use of the nanotainers for any test other than HSV-1.
Theranos has not worked to alleviate the confusion. In the company’s second statement last week, the company grossly oversimplified their work:
Here are the facts:
There are just 3 steps to Theranos’ groundbreaking finger-stick technology.
1. Take a few drops of blood.
2. Put the blood in the Nanotainer™ tube.
3. Analyze the blood.
That’s it. 3 simple steps. 1, 2, 3.
Jokes abounded on Twitter, but did little to shed any light on point #3, and in today’s conversation, Holmes all but discounted the importance of point #2, saying that the company’s nanotainers, “have nothing to do with what we can run on the devices in our lab, it has nothing to do with our tests, it has nothing to do with our testing methodology, or the accuracy or performance of it.” Indeed the long rebuttal published this afternoon also downplays the tubes calling them, simply, “the transportation vehicle for the few little drops of blood.”
Much of the rebuttal is a list of he said/she said. Theranos says they provided the WSJ reporter with a list of sources happy to speak on the record; he chose to use his own sources. WSJ says that Heather King stated that wording was removed from the Theranos website “for marketing accuracy”. Theranos says, “Ms. King said no such thing.” Theranos says the company fully explained the proficiency testing to the reporter, but he did not include that explanation in his reporting.
Theranos also challenges the anonymous sources that the Journal quotes questioning the Theranos technology. “By making them anonymous, readers do not know when they worked at Theranos, or for how long; whether they even worked in Theranos’ laboratory, as opposed to some other division in the company; or why they left,” the rebuttal statement said. The Wall Street Journal answered, “We assure [Ms. Holmes] and our readers that our sources were well positioned to know the information they provided about Theranos, and they were vetted before publication.”
But the Theranos rebuttal does link to the FDA’s decision summary for the Theranos Herpes Simplex Virus-1 (HSV-1) IgG Assay, giving a bit of a peek inside the Theranos black box.
According to the filing, samples can be either fingerstick whole blood samples or venous blood. One sample at a time is processed on a Theranos Sample Processing Unit (TSPU), which has a touch screen and accepts a single Theranos cartridge through a cartridge door. The door is never open more than 120 seconds to maintain temperature within the TSPU.
For the HSV-1 test, the process from cartridge load to test results takes about 78 minutes and includes creation of sample and a control for each cartridge, three incubation steps, a wash cycle, and a chemiluminescence reaction, in which light is detected and analyzed by the “Theranos System”—all of which happens within the TSPU using sample and other reagents from the cartridge.
A study estimating the precision of the assay using venous blood was conducted on 35 TSPU devices; the same study estimating the precision of the assay using fingerstick blood was conducted on 36 TSPU devices. The Theranos Laboratory Automation System is also listed as an instrument used for the assay, and it’s noted that the TSPU is calibrated by the manufacturer.