PHILADELPHIA — A long-awaited scientific presentation by Theranos CEO Elizabeth Holmes on Monday amounted to a plea and a promise:
Forget the past. We’ll redeem ourselves soon.
Holmes declined to provide any data about the company’s controversial Edison platform for running diagnostic tests based on a single finger prick of blood. The company voided results for thousands of those tests earlier this year, after their accuracy came under fire.
Instead, Holmes unveiled a new device called the miniLab, which has been in development for the past five years. It’s meant to condense blood testing technology that would normally require several large machines into a single desktop device.
Holmes presented internal data showing that the platform can handle an eclectic menu of tests, ranging from general lipid panels for cholesterol to more specialized tests, including one for Zika. Eventually, she said the miniLab would be able to test tiny quantities of blood for viral or bacterial infection; analyze blood chemistry, including enzymes and fats; probe for problems in the immune system; and assess blood components such as platelets and white blood cells.
But she did not suggest any kind of timetable for getting the miniLab on the market.
And Theranos did not release any data that’s been validated by a third party or subjected to peer review.
It’s also an open question how unique Theranos’ technology will be: Plenty of other companies are also working on portable lab tests.
David Koch, a professor of pathology and laboratory medicine at Emory University, called the miniLab a “‘me-too’ thing,” not too distinct from other devices.
“I wonder why Theranos didn’t disclose this information sooner,” said Serge Cremers, an associate professor of clinical chemistry at Columbia University. “The data seemed absolutely fine. But it’s not that special.”
Theranos said the miniLab would be different from other technologies on the market because it would test for far more diseases and conditions — indeed, eventually it’s meant to be capable of running 160 distinct tests. Outside experts said that would indeed be a big step forward — if it works.
“I’ve never seen anybody put this much stuff in a box,” said Danyel Tacker, associate professor of pathology at West Virginia University.
Such a device could, in theory, reduce the operating costs for hospitals, she said; if a battery of diagnostic tests could be run on a single device, then fewer lab technicians would be needed. Testing equipment would also take up far less space.
The portable miniLab could also be used in war zones or in hospitals that have limited access to clinical laboratory services.
But some experts warn that promoting cheap and convenient tests could backfire, if patients sought to test themselves too often, driving up costs in the health care system and raising the risk of scary false positive results.
No external validation
The overriding question on Monday was whether the technology really works.
Holmes said Theranos is working on letting other labs validate the miniLab. So far, though, all it has to offer is internal data.
And members of the audience were skeptical about that data, given the fiascos of the past two years.
Federal regulators have banned Holmes for two years from the diagnostics industry, after the Centers for Medicare & Medicaid Services found that Theranos’s lab practices led to “immediate jeopardy to patient health and safety.” The company is also under a federal criminal investigation for possibly misleading investors about its activities — and the value of its technology.
The presentation Monday at the annual American Association for Clinical Chemistry here in Philadelphia was widely seen as Holmes’s last chance to regain credibility in the industry. The valuation of her company has slid to near zero, from a high of $9 billion.
There was a full house for the presentation, with a long line to get in the door. (The music that played as the crowd waited: The Rolling Stones’ “Sympathy for the Devil.”)
The crowd watched in somber silence for the 45-minute talk, which included photos of the miniature centrifuge, robotics and “nanotainers” for blood samples that make up the innards of the miniLab. Then audience members peppered Holmes with questions, breaking into applause for particularly tough queries.
Holmes did take a minute to acknowledge the controversy swirling around Theranos.
“We take full responsibility of our lab operations, and are working diligently to rectify all outstanding issues,” she said.
But she wouldn’t go much further than that. Instead, Holmes sought to distance the company from the blood testing platform it had been touting for several years as a revolutionary technology. That platform, called the Edison, is no longer in use, she said, and she declined to answer questions about it.
“We know there’s a lot of questions about the past, and in the appropriate forum, we’ll address those,” she said.
Holmes tried to shift focus instead to the new miniLab.
Theranos has submitted a Zika test, using the miniLab, to be evaluated by the Food and Drug Administration. It has already received approval for a herpes simplex test, for the virus known as HSV1. The data that led to that approval in July 2015 was performed on a prior version of the miniLab, not the Edison.
Ilia Vinogradov, chief scientific officer of an Illinois home diagnostics company called Home Access Health, said he found Holmes’ presentation “impressive,” but thought it was “kind of questionable” to meld several diagnostics technologies in one apparatus, because the room for error that way is high.
“She did show that Theranos has some actual science — but she had so many claims in the beginning, and this doesn’t quite live up to them,” he said.
Pathology professor Koch, however, gave her credit for showing up.
“I was happy she acknowledged the mistakes,” said Koch, a former president of the AACC. “It showed a lot of fortitude on her part.”
I disagree. Look at: http://news.health.com/2014/07/15/home-blood-pressure-monitoring-likely-saves-money-study-finds/
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