Under fire since last fall for the murky science behind its fingerprick blood tests, Theranos has finally presented data at a scientific conference. But the presentation seemed to be more deflection than elucidation, with CEO Elizabeth Holmes detailing new projects rather than explaining how its existing tech works.
Theranos has been criticized for keeping its tech under wraps and has, until now, declined to present at scientific conferences or publish its science in peer-reviewed journals.
In a presentation on Monday at the American Association for Clinical Chemistry’s annual meeting in Philadelphia, Holmes unveiled the Theranos Sample Processing Unit, or miniLab, a platform that allows diagnostic testing in a “decentralized setting, while maintaining centralized oversight.”
The miniLab is designed to process small blood samples using the company’s capillary blood collection devices, the Sample Collection Device and its proprietary Nanotainer tubes, which were exposed last year as unapproved medical devices.
According to Theranos, the new platform will integrate miniaturized analytical testing equipment into a device that could potentially be used outside the lab. Last month, after an investigation of the company's Newark, CA, lab, the Centers for Medicare and Medicaid Services banned Holmes from operating a lab for two years. A device that does not need to be used in a lab could be a way for Theranos to circumvent this setback.
While Theranos announced the new tech with much fanfare, experts in attendance were unimpressed. “They are using the same basic technology that we have been using all along,” said AACC President Patricia Jones, clinical director of chemistry at Children’s Medical Center of Dallas, as quoted by Bloomberg. “There are still so many unanswered questions.”
Since reports questioning the validity of its tests emerged last fall, the company has been taking steps to prove its legitimacy, including appointing a number of pathology and laboratory experts to its scientific advisory board and tapping industry execs Dave Wurtz to handle regulatory affairs and quality and Daniel Guggenheim as chief compliance officer. It dumped two years’ worth of test results from its Edison machines in May before quickly reversing its stance. And its partner and main tech validator, Walgreens ($WBA), terminated their relationship in June, resulting in the closure of all 40 Theranos Wellness Centers at Walgreens locations in Arizona.
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