Elizabeth Holmes, CEO of embattled blood-testing company Theranos, on Monday boldly took her company’s technology where it had never gone before: a medical conference.
During a packed late-afternoon session, Holmes claimed her company had developed a sophisticated “miniLab” capable of carrying out an array of tests, including detecting the Zika virus, from a finger prick of blood.
Holmes made her statements in front of a skeptical audience of scientists, doctors, and lab professionals at the American Association for Clinical Chemistry in Philadelphia.
Holmes’s presence at the meeting was controversial because her company, which had claimed it would revolutionize blood testing, was instead found this year by federal investigators to have marketed inaccurate tests and potentially endangered patients.
Holmes, once lauded as the next Steve Jobs, now faces a two-year ban from operating a clinical lab, which she may still appeal.
Holmes called the new automated device the result of years of secretive research and described it as “a single platform” able to carry out a wide array of different test types using small volumes of blood. Holmes said the Zika virus test had been submitted to the FDA for approval.
“We chose this meeting to begin engaging in a scientific exchange,” said Holmes. “We wanted to introduce the invention.”
Holmes seemed to view the event as a chance to relaunch her company, calling it an “inflection point.” But instead of presenting data on the accuracy of its earlier tests, as expected, Holmes instead unveiled what she called the “latest version” of Theranos’s device. The technology she described, however, roughly echoed the unproven breakthroughs previously claimed by the company.
The new miniaturized device, Holmes indicated, would allow lab tests to be “decentralized” and carried out at more locations. She said it would communicate over the Internet, allowing centralized verification of test results.
“We know there are a lot of questions about the past, and we will address those in the appropriate forum,” Holmes said.
Just a year ago, Theranos was valued by investors at $9 billion, and the company was claiming it could carry out dozens of diagnostic tests from a mere finger pick of blood and for a fraction of the cost that other labs charge. Holmes, who founded Theranos at the age of 19, after dropping out of Stanford, claimed the technology would democratize blood tests.
Starting in 2013, Theranos opened over 40 wellness centers around Phoenix, Arizona, mostly in Walgreens drugstores. Holmes also lobbied for an Arizona law letting patients purchase medical tests without a doctor’s note, which she suggested they would do as a form of preventive medicine.
But researchers began airing doubts about Theranos, pointing out its big claims weren’t backed up by any scientific publications. That remains the case, despite Holmes’s hourlong presentation on Monday, including videos of the instrument in action.
Theranos's story began to unravel last October, when a probing Wall Street Journal investigation alleged its technology, a special device then known as Edison, and apparently the predecessor of the miniLab, didn’t work and that Theranos had been diluting samples to run them on regular lab machines.
Joel Dudley, a researcher at the Icahn School of Medicine at Mount Sinai, was an author of the only peer-reviewed evaluation of Theranos’s blood test results, which it carried out without the company’s involvement by recruiting 60 volunteers to undergo Theranos finger prick blood tests as well as standard tests.
“We were sort of shocked to find that there were no data on Theranos,” says Dudley. He says the Theranos results were different from standard tests although “they didn’t deviate as much as you’d think.” Nevertheless, the U.S. alleged that Theranos’s lab was so poorly run it put patients in danger.
Holmes’s new technology is unlikely to convince skeptics of the company, whose value Forbes estimates has fallen to close to zero. “I can’t imagine anything that would be said at this point to resurrect Theranos,” said Arthur Caplan, a bioethicist at NYU. “This is more like buffing a very dirty magical lantern than it is the proper way to reclaim scientific standing.”
AACC president Patricia Jones said the organization had been asking Holmes to present for several years. “Of all places, I am really glad it is here in front of a huge audience of experts,” says Jones.
Ahead of Holmes's presentation, Eleftherios Diamandis, a researcher at Mount Sinai Hospital who has written a series of opinion papers in the journal Clinical Chemistry and Laboratory Medicine critiquing the Theranos technology, said that any claim made by the company “will be speculative until validation shows that it is true.”
When asked if Theranos would be sharing its miniLab device with other scientists, Holmes said that she is “working on it right now.”
Stephen Master of Weill Cornell Medical College was part of a panel of experts given the chance to ask Holmes questions. He earned applause for reminding Holmes that she had once claimed to be able to run scores of tests from a single blood sample, a claim she did not repeat in Philadelphia.
Master said the main novelty of the miniLab seemed to be how it combined several conventional tests onto one system, something he said is certainly possible. “The engineering looks fine,” he said. “If there hadn’t been all the hype and talk of transforming laboratory medicine, I think we would have looked at this differently.”