Just a few short years ago, biomed startup Theranos was a media darling, and founder Elizabeth Holmes was being lauded as a self-made billionaire. All it took to topple Theranos was an article from John Carreyrou asking some tough questions about the company’s Edison blood testing machine. With the company now shuttered, former CEO Holmes is facing charges for defrauding investors. According to laboratory managers called to testify, Holmes should have known Edison was a dud, Ars Technica reports.
Holmes dropped out of college in 2003 at age 19 to start Theranos. The goal of the company’s secretive Edison technology was to conduct assays on smaller samples of blood, what you’d get from a finger stick as opposed to a syringe. Traditionally, scientists and engineers believed this was impossible because finger sticks are much “messier” samples with cellular debris and skin mixed in with the blood. Still, Theranos claimed Edison could do it. Naturally, a lot of companies were interested.
Theranos eventually contracted with numerous pharmaceutical firms to develop tests for Edison (below), something that Holmes has leaned on repeatedly in her defense. Holmes told investors that Edison had been “comprehensively validated” by multiple big pharma outfits. That meant Edison worked, and therefore she was not guilty of fraud. The problem, however, is that the laboratory managers who tested Edison are still around and willing to give testimony.
Prosecutors had Victoria Sung from Celgene on the stand and asked point-blank if Edison was “comprehensively validated.” Sung was clear that, no, the machines were not validated. In her testing, Edison machines failed to produce valid results over 14 percent of the time, far higher than the 2 percent rate of the industry-standard QPS test that uses more blood. That put it far outside the realm of clinical usability, so Celgene backed out of the deal.
Also in court on Thursday was former Theranos lab manager Dr. Adam Rosendorff, who confirmed that he signed off on results that he did not believe were accurate. He claims he did this under pressure from Holmes and COO Sunny Balwani, who was also Holmes’ squeeze at the time. Rosendorff also explained how Holmes and Balwani had ordered workers in the Edison lab to remain inside with the door closed when government inspectors came calling. That implies Holmes knew about the issues with Edison while she was telling investors that it worked like a charm.
The testimony is not shaping up well for Holmes so far, and prosecutors have much more to present.
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