Elizabeth Holmes Lifts the Veil on Theranos Technology at AACC

Theranos has taken a first step in trying to rehabilitate its image among the scientific community. In a widely anticipated special session at the American Society of Clinical Chemistry’s 68th Annual Scientific Meeting and Clinical Lab Expo (July 31-Aug. 4, Philadelphia), Theranos CEO Elizabeth Holmes took the stage to discuss the company’s technology—at least some of it. She opened by addressing the elephant in the room—government sanctions regarding Theranos’ California laboratory—but only to say that “we take full responsibility for our lab operations and we are working diligently to rectify all outstanding issues and to realize the highest standards of excellence in lab operations.” What she really came to do, she said, was not to discuss lab operations but rather to introduce “key inventions” and “the associated science and results behind our technologies” and engage in an “exchange of scientific information about our inventions and technologies.”

Holmes detailed the “architecture” of what the company has named the miniLab and the Theranos Virtual Analyzer (TVA), which facilitates testing across different methods in a miniature platform. The miniLab is a compact device (2.5 cubic feet) containing a mini-robot that processes single-use cartridges with the TVA remotely dictating protocols for processing. Holmes indicated the technology is not yet FDA approved but the company is working toward that goal and is currently pursuing FDA emergency use authorization for a Zika assay.

Following the presentation, AACC representatives Dennis Lo, M.D., Stephen Master, M.D., Ph.D. and Patricia Jones, Ph.D., and President of AACC moderated a question and answer session. Dr. Master noted that the evidence Holmes presented “fell far short of” prior very broad claims—for example, that Theranos technology could facilitate a “whole panoply of lab tests from a couple drops of blood.” Holmes responded that this presentation was to begin engaging “in a scientific exchange” and discuss the architecture of one of its latest inventions. She did, however, acknowledge that “we fully understand … we have a lot of work to do to engage with this community … I wish that I had started earlier in the context of building the scientific and medical board that we’ve had the privilege to build and now working toward peer reviewed publications.”

In an interview with G2 Intelligence, Dr. Jones later said that Holmes “didn’t support her initial claims” and “they have a lot of answers still to provide” but the miniaturization and connectivity of the miniLab and TVA were impressive. She added: “They still need to publish. They still need to get their data out there and prove that everything they’ve said can work. But I think they’ve made a great start and they have enormous potential.”