Score for Theranos after AACC: Fail.

Elizabeth Holmes: Data? What data? Scientists: We’re not impressed.

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This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group.

Theranos logoSKEPTICS WHO WEREN’T EXPECTING MUCH from Theranos CEO Elizabeth Holmes at the recent American Association of Clinical Chemistry’s annual meeting were proved right: Instead of delivering scientific data and making her case that the diagnostic technology claimed by in recent years was indeed both disruptive and revolutionary, the controversial executive … punted.

THE DARK REPORT was there, and what the AACC crowd of 2000+ heard instead was a presentation of an unimpressive lab testing instrument, Theranos’ new business strategy; and correlation data for assays that used decidedly conventional methods and ordinary venous blood.

If you were at the AACC meeting, what where your thoughts after Holmes finished her presentation?

Holmes opened her presentation by unveiling what she described as Theranos’ newest-generation lab analyzer, which she called the “miniLab.” Following a series of short videos that showed how this lab instrument operated, Holmes then put up slides showing data generated from the correlation of lab assays run on the miniLab.

It was obvious to the audience—and the very large contingent of journalists present in the hall—that Holmes was refusing to show any of the data associated with the lab testing technologies that she has touted during the past three years.

The consequences of her decision not to deliver the information promised in advance of the presentation were immediate. During the next 24 hours, most major news outlets in the United States published stories about her speech, along with the reaction of the AACC’s membership to the information she provided.

Taken collectively, news coverage of Holmes’ speech showed that Theranos no longer has much credibility with news reporters. Most of these news stories carried quotes by clinical chemists and pathologists who listened to Holmes and expressed skepticism about the new analyzer and testing model that Holmes introduced.

Clinical chemists and lab scientists who were in the conference hall had plenty to say after Holmes finished her presentation. The reaction of these clinical lab professionals in the audience was generally negative on three points. First they reacted negatively to Holmes’ decision not to present scientific data on her lab company’s self-described disruptive innovations. Second, many clinical chemists objected to how she delivered a commercial speech at a scientific meeting.

Third, lab scientists reacted to the lab instrument and assay correlation data that Holmes did present. The general sense of the scientific community was that the instrument—a desktop device of about 95 pounds with miniaturized internal components—appeared to use conventional technologies not much different than these clinical labs use daily. Also, during the question and answer session, it was pointed out to Holmes that the assays and correlation data generated by her miniLab analyzer used conventional methodologies and venous blood.

Stated another way, Holmes did not show an analyzer capable of doing “up to 70 tests on a single drop of blood.” Nor did she present data that demonstrated that capability.

What nearly all the news reporters missed, but what did not escape the notice of the clinical chemists and pathologists in the room, is that Holmes had described a business model for clinical laboratory testing that represented a huge shift from what Theranos has been doing in recent years: specimens collected in retail pharmacies, like Walgreens, are then tested in its CLIA lab facilities in Newark, Calif., and Scottsdale, Ariz.

Statements made by Holmes during the presentation illustrate the different direction that Holmes appears to want to take Theranos, compared to the public statements of the past three years. However, before it can bring this business model to the clinical marketplace, Theranos will have to meet stringent FDA and CLIA requirements.

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