A look inside the miniLab that Theranos previewed at the AACC Annual Scientific Meeting in Philadelphia this week.
I rarely pay attention to the music leading up to a keynote presentation. But as I waited for Theranos CEO Elizabeth Holmes to take the stage at the American Association for Clinical Chemistry Annual Scientific Meeting, the first person leading a company under criminal investigation to address scientists there (according to one member of the conference’s media relations team), I was struck when they played Sympathy for the Devil by the Rolling Stones. It seemed like a bad omen for the business or the work of an organizer with a dark sense of humor. It was fitting.
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The audience had been looking forward to hearing data on the company’s blood testing technology that had gotten Theranos into so much hot water with the U.S. Food and Drug Administration, the Centers for Medicare and Medicaid Services and U.S. Justice Department. Instead, they got an introduction to a new product — the miniLab. The device is designed to process small capillary whole blood and plasma samples, according to a news release.
The diagnostics company presented preliminary data that Holmes claimed showed its effectiveness with a group of diagnostic tests. But there was nothing in the way of peer-reviewed data, so it felt more like a sales pitch than the rigorous studies that tend to be presented at this conference.
Lay-person language: The #Theranos miniLab takes equipment used in a standard lab & puts it in a single box. Decentralizes the lab #AACC2016
— Christina Farr (@chrissyfarr) August 1, 2016
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The miniLab is also designed to be operated remotely through the cloud, according to a news release. Lab tests performed in one location could be interpreted by a central lab somewhere else.
Applause when asked why data was from venous blood, not capillary as advertised. "We wanted to…We're working on that." #AACC2016
— Michael H. Tomasson, MD (@MTomasson) August 1, 2016
Yet the data Holmes presented with fellow scientists was from venous draws, disappointing those expecting data on its fingerstick technology.
Theranos has submitted a test for the Zika Virus for emergency use authorization. It comes at a time when there are fears of a growing outbreak of the disease after 10 cases of Zika transmitted within the U.S. have been identified in Miami, Florida. Despite the growing threat Zika poses in the U.S., the enormity of the baggage Holmes brought with her to the conference dampened the interest in this particular piece of news.
One general grumble by scientists at the event was that Theranos simply took tests that are already available and miniaturized them. A Bloomberg interview with Geoffrey Baird, an associate professor of laboratory medicine at the University of Washington, reflected the collective anger over how Holmes used the conference:
“It is a bait and switch…We were told we were going to hear about the science of Theranos. This is a new speculative prototype idea that they have,” he said in an interview shortly before the presentation. “It is a completely different instrument” than what Theranos had previously talked about.
The preview of a prototype device with no timeline offered for regulatory approval gives one pause as to how the company will have the means to commercialize the miniLab considering how much credibility Theranos has lost. Given the fact that the diagnostics business felt compelled to void its test results for the past two years and lost what seemed like a lucrative contract with Walgreens, the audience was not impressed with the product preview.
https://twitter.com/Rachakonda_V/status/760234383626215424
Holmes is not answering direct questions. Is she looking for investors? #AACC2016 #Theranos
— Mara Neal (@NealMara) August 1, 2016
Theranos CEO: "know there's a lot of Qs about the past," and will address them in "appropriate forum" #AACC2016
— Meg Tirrell (@megtirrell) August 1, 2016
There were bursts of applause during the Q&A section when a hard question was leveled at Holmes such as how her presentation has not addressed previous claims by Theranos. Holmes, who never lost her composure, simply shrugged off these questions, making it feel like she had accomplished far more than many in attendance would have liked. She used her infamy to generate massive numbers of attendees and used her time to show them a new product. It was a gamble, but whether it will pay off in the long-term remains to be seen.
You can check out the presentation by Holmes below.
