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Theranos founder Elizabeth Holmes

Expecting Data From Theranos, Lab Experts See New Product

Aug. 2, 2016
Facing a two-year ban from running a clinical testing company, Theranos founder Elizabeth Holmes introduced a “miniLab” tabletop testing device. Not everybody was impressed.

It was expected to be an academic presentation to show whether Theranos Inc.’s controversial blood-testing technology worked, and perhaps explain the science behind the claims that the startup could do lab tests with a fraction of the blood and cost of traditional machines.

Instead, what some of the nation’s top lab-testing scientists and researchers packed into a ballroom at the Pennsylvania Convention Center in Philadelphia got was the introduction of a totally new device.

Founder Elizabeth Holmes, who is facing a two-year ban by U.S. regulators from running a clinical testing company, used the session at the American Association for Clinical Chemistry’s annual scientific meeting to introduce the “miniLab” testing device, a 95-pound diagnostic tool that can fit on a tabletop. The device isn’t yet for sale and hasn’t been approved by regulators, Theranos said in a statement.

Along with the new device came a scaled-back vision for the company that not long ago, promised to upend the world of clinical lab testing by running hundreds of tests using a single drop of blood. The miniLab appears to pack a variety of tests that can already be done on a small scale into a single box.

“They are using the same basic technology that we have been using all along,” said AACC President Patricia Jones, Clinical Director of Chemistry at Children’s Medical Center of Dallas. “But they have miniaturized it. They have put it all in a small platform.”

It’s also not clear how many tests Theranos has validated for use on the machines, or how many finger pricks to collect blood will be needed. “They have a lot of work to do,” Jones said. “There are still so many unanswered questions.”

That assessment was echoed by Stephen Master, a pathologist at Weill Cornell Medicine who helped moderate a question and answer session after Holmes’s presentation: “It is certainly not yet a game changer,” Master said. While the instruments they presented appeared to have some good engineering behind them, “I certainly didn’t see anything that lives up to the expansive claims they made.”

At the session, Holmes showed several slides comparing test results run on the new machine to existing accuracy standards, including one for a cholesterol panel, that appeared to show the new machine was within guidelines. That wasn’t enough for Master.

“I can buy a point-of-care instrument that does a lipid panel,” he said, referring to existing products already on the market that can run cholesterol tests in a doctor’s office.

The company also said it has developed a test for Zika virus with the miniLab machine that’s been submitted to the U.S. Food and Drug Administration. Angela Stark, an FDA spokeswoman, declined to comment on whether or not the agency had received an application.

While the new device may run a smaller number of tests, “the technology appeared to generate results that compared well to existing technologies and that were highly reproducible,” said Eric Schadt, director of the Icahn Institute for Genomics and Multiscale Biology at the Icahn School of Medicine at Mount Sinai.

In introducing the new device, Theranos attempted to hit the reset button. Theranos stopped using an earlier version of its technology, called Edison, after questions arose about their accuracy. The company eventually voided or altered thousands of test results, and some attendees wanted badly to see the company defend or explain its past efforts.

Bait and Switch?

“It is a bait and switch,” said Geoffrey Baird, an associate professor of laboratory medicine at the University of Washington who has been a critic. “We were told we were going to hear about the science of Theranos. This is a new speculative prototype idea that they have,” he said in an interview shortly before the presentation. “It is a completely different instrument” than what Theranos had previously talked about.

The AACC’s Jones introduced Holmes and said that the session wasn’t an endorsement of the company. “This session, as everyone is pretty well aware, has been controversial. … “We want to see how this works, and that it works.” Among her colleagues, almost “everybody is pretty highly skeptical.”

Announcing Holmes’ intent to appear at the meeting in April, the AACC said that its members — who represent clinical lab testing professionals, researchers and doctors — would see the company “clarify the science, accuracy, and reliability of Theranos’ technologies, as well as its impact on patient care and safety.”

Once lauded as a potentially revolutionary company in the lab industry, Theranos has fallen far. U.S. inspectors said they found failures so severe as to jeopardize patients’ health at Theranos’s lab in Newark, California, leading to proposed sanctions this year that would ban Holmes from running a laboratory company for two years, along with monetary penalties and cancellation of payments from federal health insurance programs.

“We take full responsibility for our lab operations and are working diligently to rectify all outstanding issues,” Holmes said during her presentation Monday.

The company also has also come under scrutiny by House Democrats, the U.S. Securities and Exchange Commission and the U.S. Attorney’s Office for the Northern District of California. Researchers have called on the startup to publish data supporting its technology in a peer-reviewed scientific journal, where independent scientists could evaluate the data, which it has yet to do.

By Robert Langreth and Caroline Chen

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Licensed content from Bloomberg, copyright 2016.

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