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Outside the Lab Technology and innovation, Quality assurance and quality control, Laboratory management, Clinical care

Too Little, Too Late?

Is anybody else intrigued to see where the Theranos story goes next? Nineteen-year-old Elizabeth Holmes starts a diagnostic company that, 11 years later, is valued at $9 billion – allowing her to boast a net worth of $4.5 billion. It sounds like the stuff of fairy tales or, if things go wrong, nightmares.

Alarm bells have been ringing for quite some time. Not surprising, given that claims of viability and accuracy of its secret but “revolutionary” fingerprick testing technology were based on data never released.

Theranos is now fighting for survival, after US regulators revoked its license to operate its Californian lab. Holmes has been banned from the blood-testing business for at least two years – and a federal criminal investigation is ongoing. All this action comes off the back of a startling revelation uncovered by Wall Street Journal: Theranos’ flagship “Edison” technology was not being used to run its single drop diagnostic tests; rather, generic machines were relied upon – and allegedly results were often inaccurate.

Pretty much overnight, Holmes’ net worth was revised down to zero by Forbes and Theranos dropped to $800 million. Though corporate statements assured that “corrective measures” would be taken, I thought to myself, “There’s no coming back from this.” And yet, there I was, sitting in a packed hall at the AACC’s annual congress in Philadelphia, eagerly awaiting Holmes’ grand entrance – along with over 1,000 others, including national press. It was her opportunity to redeem herself – and I can’t deny, I half expected a no-show. Kudos to Holmes, who braved the room full of critics to “lift the lid” on a new technology (note: not Edison). The miniLab, Holmes claimed, will “miniaturize laboratory testing.”

The presentation included demo videos and subsets of data, followed by a live Q&A. Though she appeared confident, the data had not been validated or peer reviewed and, if I’m honest, the presentation felt a little like a sales pitch – a risky approach in front of an intelligent audience. I know that Holmes was not there to defend herself or discuss the current investigation, but I felt that some honesty on the current situation would have been welcomed.

“Our hope is to be able to work with all of you in validating and testing [our panels],” she said. “We will work as hard as it takes to be able to realize [our] vision.”

Did she manage to convince? Based on the mood in the room, I think she still has a lot of work to do.

Fedra Pavlou

Editor

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About the Author
Fedra Pavlou

After graduating with a pharmacology degree, I began my career in scientific publishing and communications. Now with more than 16 years of experience in this field, my career has seen me heading up editorial and writing teams at Datamonitor, Advanstar and KnowledgePoint360 group. My past experiences have taught me something very important – that you have to enjoy working with, and have respect for your colleagues. It’s this that drew me to Texere where I now work with old colleagues and new. Though we are a hugely diverse team, we share several things in common – a real desire to work hard to succeed, to be the best at what we do, never to settle for second best, and to have fun while we do it. I am now honored to serve as Editor of The Pathologist and Editorial Director of Texere Publishing.

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