Coverage: Elizabeth Holmes tries to salvage Theranos

Theranos Inc. founder Elizabeth Holmes presented a new blood-testing device to the medical world on Monday in a bid to save the company that has had to retract the findings of its previous blood testing results.

John Carreyrou of The Wall Street Journal had the news:

Speaking before an audience of laboratory scientists at the annual meeting of the American Association for Clinical Chemistry, Ms. Holmes described a device called “miniLab,” resembling a computer printer she said could run tests accurately on small sample volumes.

“We’re pleased to share our technologies with the entire laboratory industry. It’s the beginning of the next phase of the company, as we introduce our technologies to the world,” Ms. Holmes said in a news release issued during her remarks. “We also will be working with academic institutions and other independent parties to validate and publish our results.”

The Palo Alto, Calif., company said its miniLab hasn’t been approved by the Food and Drug Administration.

Theranos voided two years of earlier test results and sent tens of thousands of corrected test reports to patients and doctors. Those moves followed an inspection by the Centers for Medicare and Medicaid Services that concluded the company’s Edison machines failed quality-control checks and other gauges of accuracy.

Abigail Tracy of Vanity Fair notes that her presentation in Philadelphia fell short of a full disclosure:

Standing before a crowd of researchers and lab testing professionals Monday at the annual meeting of the American Association for Clinical Chemistry, Holmes mostly side-stepped the controversy surrounding Theranos’s questionable diagnostic testing device, Edison, taking the opportunity to present the beleaguered start-up’s new “miniLab” diagnostic tool, Bloomberg reports. The 95-pound table top-sized prototype, which uses a small lab robot to perform diagnostic tests on small blood samples, is designed to improve access to laboratory testing, Holmes said. The 32-year-old founder, who previously held the title for the world’s youngest self-made female billionaire (at least on paper), also discussed the company’s plans to decentralize diagnostic analysis by moving the process to the cloud with what Holmes called the Theranos Virtual Analyzer, Forbesreports. Neither the miniLab or the cloud-based technology have been approved by the F.D.A.

While Holmes did present some data on the success of its diagnostic tests, the presentation—which was not peer-reviewed—reportedly left many unsatisfied. Addressing Theranos’s previous claims to be able to run dozens of different tests on a single drop of blood, moderator Stephen Master told Holmes, “the evidence you presented fell far short,”Business Insider reports. The crowd applauded.

Much of the blood-testing data Holmes unveiled during her 90-minute presentation was based on traditional methods, not the promised single-drop method that Theranos previously touted as revolutionary. “We’re pleased to share our technologies with the entire laboratory industry. It’s the beginning of the next phase of the company, as we introduce our technologies to the world. We also will be working with academic institutions and other independent parties to validate and publish our results,” Holmes said in a statement. “The results we’ve presented demonstrate the inventions behind, and some of the analytical performance capabilities of, the miniLab system,” she continued, adding that Theranos hopes to receive F.D.A. approval “in the coming years.”

Robert Langreth and Caroline Chen of Bloomberg noted the skepticism that Theranos faces:

“It is a bait and switch,” said Geoffrey Baird, associate professor of laboratory medicine at the University of Washington. “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. Baird has been a critic of the company in the past.

AACC President Patricia Jones, a professor of pathology at the University of Texas Southwestern Medical Center in Dallas, introduced Holmes, saying that the session wasn’t an endorsement of the company. “This session, as everyone is pretty well aware, has been controversial.”

The company 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.

In introducing the new device, Theranos appeared to be attempted to hit the reset button. The miniLab is different from what Theranos called Edison, the devices it developed for commercial lab testing of patients blood testing. Theranos stopped using the Edison devices after questions arose about its accuracy. The company eventually voided or altered thousands of test results.