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Theranos’ Highly-Anticipated Defense of Its Tech Is Called a ‘Bait-and-Switch’

Aug 01, 2016

Elizabeth Holmes, CEO of embattled blood testing company Theranos, was expected by many to share information about her controversial diagnostics technology during a highly anticipated appearance at a medical conference on Monday. Instead, she went in an entirely different direction.

Rather than address the many regulatory and accuracy concerns about Theranos' Edison blood testing machine, Holmes pitched a new technology called the "miniLab" at the American Association for Clinical Chemistry (AACC) convention in Philadelphia on Monday. The device, which the company says will be able to perform blood diagnostics remotely, isn't yet available and hasn't been cleared by the Food and Drug Administration (FDA).

"It’s the beginning of the next phase of the company, as we introduce our technologies to the world," said Holmes, who was recently banned by the Centers for Medicare and Medicaid Services (CMS) from operating a blood lab for at least two years.

Holmes' remarks were widely criticized by doctors attending the packed event who had expected to be provided data about Theranos' Edison machine. The company had bragged that it could diagnose a number of conditions using mere drops of blood rather than vials, and that it could do so more cheaply than conventional diagnostics.

However, Theranos was forced to throw out two years' worth of data from Edison tests and to issue tens of thousands of corrected test results to doctors.

Following Holmes' presentation, several physicians and scientists in the crowd asked her tough questions about the company's technology, leading some attendees to applaud. Holmes responded that she realized that there were "many questions" about the Edison devices, but that those would be addressed at an "appropriate forum" at a later time.

Some took to social media to share their skepticism.

Geoffrey Baird, a professor of laboratory medicine at the University of Washington and a Theranos critic who attended the session, echoed the "bait and switch" line in an interview with Bloomberg. AACC President Patricia Jones was careful to note on stage that the "controversial" presentation did not imply that AACC endorsed the company.

Fortune contacted Theranos about the company's plans for Edison and whether more information would be made public.

"Edison is the name of the early testing system," the firm replied in a statement while adding that it would continue to invest in and promote that technology. "As Elizabeth said on stage, there will be an appropriate time and place to talk about the past. Today’s presentation was about Theranos’ present, and about its future."

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Theranos has been trying to convince the public and regulators that it's making serious changes to its management and operations after intense scrutiny of its practices. It hired a well-regarded medical board in April and enlisted the help of two veteran biopharma executives in July. Still, the company has been reeling from a collapsed deal with Walgreens (wba) to provide its tests at the pharmacy chain's "Wellness Centers," regulatory and Congressional inquiries, and consumer lawsuits.

But that did not dissuade Holmes from going into sales mode on stage. She mentioned preliminary data that she said shows how the miniLab is effective across a variety of diagnostics and said her company would let academic institutes conduct peer reviewed testing of the miniLab's accuracy. Holmes also emphasized that Theranos is developing a test for Zika virus that can be used with the system. That test has been submitted for FDA approval, she said.

Holmes touted the miniLab as an integrated platform that's "designed to process small sample volumes" of blood and that it can be operated remotely with the help of a central software hub.

"We hope to achieve FDA market authorizations of these exciting technologies in the coming years," she said.

Correction: Aug. 3, 2016: This post has been updated to reflect that Holmes did not technically "promise" to address Theranos' old technologies specifically, although that's what many attendees originally expected after the AACC announced her presentation in April. "For the first time, Holmes will present data at a scientific conference that describes Theranos’ technologies, including small sample volume testing and finger-stick collection," the organization wrote at the time.

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