Just before Theranos CEO and founder Elizabeth Holmes took the stage in front of a conference room packed with of thousands of skeptical doctors, the PA was playing the Rolling Stones' "Sympathy for the Devil." The irony was clear. Since October 16, 2015, Holmes has spent every public moment defending her company against mounting evidence that their drop-of-blood diagnostics service was built on a scientific sham. Many of the people gathered in that conference room at the 2016 annual meeting of the American Association of Clinical Chemistry were probably expecting the company to address those allegations, with data. Instead, they got a box.
The box, called miniLab, is a tidy, humbled version of the mythos that made Theranos a $9 billion unicorn. According to Holmes, it is a glimpse of Theranos' next chapter, "an inflection point for our company." Which may have baffled the number of people who thought they had bought tickets for a reckoning. But why not? Theranos' old business model is dead, skewered by nine months of really bad press, and bled out by a recent federal ruling that bans Holmes from running a clinical testing lab for two years. So, if you take a big step back and look not at where Holmes was speaking—a medical conference—but where she was coming from—Silicon Valley—it's clear what really happened on that stage in Philadelphia. She pivoted.
Holmes and Company once promoted an innovative, breakthrough technology that would run up to 70 different tests on a single drop of blood---obtained painlessly from a finger prick---while being cheaper and faster than anything else available. Then, Wall Street Journal investigative journalist John Carreyrou published articles alleging that the company's technology was in fact, only capable of doing a few tests on a single drop of blood. Further, many of those blood drops collected from real customers had been diluted and analyzed using a competitor's technology. The recent federal ban for Holmes has vindicated the Journal's claims.
The box Holmes presented today uses analytical methods developed years ago (by other people) to run an unspecified number of tests on a small (but larger than finger prick) volume of blood, obtained by poking a needle into a person's arm. Holmes did not say how much a miniLab test would cost, nor how long it would take to obtain results. The miniLab is a bunch of standard lab equipment, miniaturized for a doctor's desktop. "They have some interesting engineering, but not anything that is at the change-the-world level they had previously claimed," says Stephen Master, professor of clinical and lab pathology at Weill Cornell Medical College. Neat.
Even before the Journal's debunking, clinical pathologists had been asking Theranos to show its validation data to prove that its tests, run on its original technology, worked as advertised. But the company had been a black box, instead using its FDA approval (which is not actually necessary for the type of tests Theranos was trying to sell before Carreyrou's exposé) as a shield from criticism. Today was a reversal. "What was impressive to me, is she unloaded mountains of data on stage, with the caveat that it was collected by her teams under the best possible testing circumstances," says Jerry Yeo, director of clinical chemistry at the University of Chicago.
And Holmes, having apparently learned her lesson, also admitted that the numbers for this new, simpler device had not yet been through peer review. Though she promised that would be happening soon. Master, who helped moderate the question and answer portion of Holmes' presentation, says he believes the miniLab data will probably do fine under scientific scrutiny. But to him, that doesn't mean Theranos has vindicated itself. The miniLab itself still has to get validated by an independent lab. And even that wouldn't give Theranos the clean slate it desires. Not from this crowd. Remember, this company got famous claiming faster, cheaper, painless, and above all revolutionary tests. Now it wants that same level of attention to pitch a mini lab that features no radically new technology. "This gets back to the meta question: Does this live up to the hype?" says Master. "The answer to that is no."
That gets at yet another controversy Theranos stirred up in the clinical lab testing community. Many AACC members were upset that Holmes was given stage time at their annual meeting. They felt it gave her and her company an undeserved patina of authenticity. "Normally if you want to give a talk at this conference, you have to submit something of a proposal to the meeting's organization committee and they will judge if you are worthy to give a presentation. Or someone is so famous, a Nobel Prize winner or well-recognized scientist who has made great strides and is invited based on their record of publications," says Yeo. "Elizabeth Holmes is none of these."
Upon introducing Holmes to the thousands of people in the plenary audience, AACC president Patricia Jones said that having the Theranos president in attendance was "a tremendous opportunity." For the gathered attendees, perhaps. The AACC's organizers had been inviting Holmes for several years: Finally, everyone would get to see the data behind the company's claims.
Or so they thought. Today's presentation focused entirely on Theranos' new product: Holmes did not take questions or talk about her company's regulatory problems. "In my mind, Theranos shouldn't get to trade on the publicity they've gotten for the trouble they've had, and then get to say to everybody, 'Oh, and you guys have to pretend we are starting from scratch,'" says Master.
Yeo agrees. "In a sense, it was very disappointing," he says. "We are not talking about basic research here, we're talking about technology that will be used to monitor disease, and actually affect peoples' lives. There ought to be some regulatory discussion as well."
Theranos used its regulatory baggage to sell the room, and then used its time on stage to bill itself as a company with a clean slate. "This sounded like a talk from a manufacturer," says Master. "And if there were no history from this company, they were coming straight off the line, I would evaluate them same as any other new instrument." But Theranos is not new, and sympathy is one thing it should not expect.
