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How Theranos’s reboot could backfire

Elizabeth Holmes, chief executive of Theranos, attends a panel discussion during the Clinton Global Initiative's annual meeting in September 2015. (REUTERS/Brendan McDermid)

Theranos chief executive Elizabeth Holmes tried to kick off the beleaguered company's comeback story on Monday in front of a few thousand scientists and doctors. She called the moment an “inflection point” and deployed all the right words: “data,” “peer review,” “publication.”

But instead of revealing the company is on a new path, Holmes's presentation seemed to highlight the ongoing disconnect between a fiercely private Silicon Valley startup and the scientific and medical communities.

Fighting against a federal investigation and lawsuits, Theranos's 32-year-old founder showcased a new technology and attempted to set a new tone for the company. Although she never called it a new age of transparency, that was the gist: "Piece by piece, we're working to put that information out there," Holmes said.

Then, she spent 45 minutes pitching the experts a new device, miniLabelaborating on its technical specifications and presenting data comparing it with other systems. The talk resembled a new product launch from the company that promised to revolutionize blood testing, although the device is not approved for any medical use.

With sanctions looming that will ban Holmes from owning or operating a laboratory, the focus on introducing a new device would seem to offer a path forward as questions hang over the company's clinical laboratory business. In an interview with Reuters after her presentation at the annual meeting of the American Association for Clinical Chemistry, Holmes christened this the “next chapter of our lifecycle.”

Who needs whom?

The company's new product wasn't the only shift. Holmes promised to provide more data on its technologies for review, after being criticized for the company's secrecy in the past.

For people in the biomedical industry, Theranos's relationship with the scientific community has been remarkably backward: Successful companies start with the wonky audiences — they're built on science that was first presented at obscure genetics conferences or on clinical trial data published in journals, and they build a business from there.

But even as the outside experts have been largely left out at Theranos until recently, the opinions, concerns and trust of clinical chemists are central to its technology — and, in the end, its commercial success. Although ordinary people would be the ones getting their fingers pricked, these are the people whose trust may matter even more — the people who run major hospitals’ clinical laboratories and the experts who want to see testing get better and cheaper but not sacrifice accuracy and reliability.

For many people watching Theranos, this worldview has come to represent what's wrong with the company. Theranos promises to be disruptive, transforming medicine and envisioning a future in which people can order their own blood tests for cheap. But even disruption needs to be built on something solid, and that was what Holmes had a chance to establish yesterday, and — for many — didn't.

Several scientists said that the presentation, insulated from the real, deep questions that have arisen about Theranos for months, was reasonable. The data seemed like a good start. One scientist, K.T. Jerry Yeo of the University of Chicago wryly commented that "clearly, someone has been teaching them how to do this." He and others noted that the major innovation seemed to be miniaturizing a number of standard laboratory tools into one box, but also said that it might be useful in certain situations.

The innovations are evolutionary, not revolutionary, said Geoff Baird, an associate professor in the department of laboratory medicine at the University of Washington.

But what hung over the entire presentation was a feeling that science was being muzzled. These were not the data that 2,650 people came to see.

The technology that cannot be named

Theranos was expected to explain its existing technology; instead, it decided to pitch a new one. The precise relationship between the new technology and the older iteration was unclear.

Questions about the older technology — or anything other than the new box Holmes described in lavish technical detail — weren’t allowed. On-stage panelists quizzed Holmes, a format that may have been logistically necessary, but also gave the presentation a smooth flow with few of the awkward moments that would have occurred if scientists had been able to stand up and ask uncomfortable and pointed questions, forcing Holmes to decline to answer.

No single presentation can accomplish everything, and Holmes acknowledged lots of work lies ahead. She said she would address problems and the past at a future time. But given a huge platform and an extremely informed audience, Holmes chose not to speak or address any of the questions regarding the company's older technology, introduced to the public in 2013.

The company in July was careful to say that the harsh federal sanctions — including the two-year ban for Holmes from owning or operating a lab — "pertained to the operations of the company’s Newark lab, not its technologies."

But the first major presentation of Theranos's data at a scientific conference, in August 2016, did not include include any of the data from the proprietary technologies that Theranos has used in the real world — and which led to two years of tests conducted on that older device being voided and corrected earlier this year.

Baird said that it was clear the company had been developing the new technology for years, but the data felt as if it was the product of an "all-nighter to prep your term paper."

The data that Theranos presented on Monday was all generated in 2016 by the company — almost as if the past months and years had simply not happened.

Correction: A previous version of this story incorrectly reported the attendance at Elizabeth Holmes' talk.