Theranos launch aims to sidestep scandals

Billionaire Elizabeth Holmes, founder and chief executive officer of Theranos Inc©Bloomberg

Theranos founder Elizabeth Holmes

Elizabeth Holmes, the founder of besieged blood-testing start-up Theranos, sidestepped questions about the accuracy of the company’s technology during a much-awaited presentation on Monday and instead unveiled a prototype of a completely new device.

Theranos miniLab©Company handout

Theranos MiniLab

Scientists had expected Ms Holmes to use an appearance at the annual gathering of the American Association for Clinical Chemistry in Philadelphia to defend the company’s existing technology, which has been tarnished by a series of scandals.

But Ms Holmes used an hour long presentation to introduce the company’s new machine — a futuristic “MiniLab” that she said would be able to generate accurate results from small samples of blood.

Those samples would not need to be physically transported to a laboratory for examination, she said, but would instead be processed in the cloud by a Theranos Virtual Analyser.

More

On this topic

IN Pharmaceuticals

The machine would “decentralise” the US blood testing market, she said.

“We chose this meeting to begin engaging in a scientific exchange,” said Ms Holmes. “We wanted to introduce this invention and the ability to run a broad range of assays,” she added, using the technical term for an investigative laboratory procedure.

“We know there are a lot of questions about the past and in the appropriate forum we will address those,” she said.

Ms Holmes presented data that purportedly showed the MiniLab performing comparably to commercially available machines and said she would eventually make it available for peer review by independent scientists.

She also unveiled a new version of the company’s “nanotainer”, a tiny finger prick vial that made the company famous when it was first made public in 2013. At the time, Theranos claimed the nanotainer could generate accurate results from a few drops of blood, negating the need for traditional needles and venous draws.

But for the past 10 months the company has been beset by a series of scandals culminating in Ms Holmes being handed a two-year ban by the Centers for Medicare and Medicaid services, the US laboratory regulator, after a string of failures that put patient lives at risk. The ban, which is due to go into effect in October, would prevent Ms Holmes from working in the blood testing industry.

Ms Holmes’ presentation met with short shrift from some blood testing experts, who noted that all the tests on the MiniLab had been carried out using traditional venous draws rather than with the nanotainer.

“It is a bait and switch,” said Dr Geoffrey Baird, an associate professor of laboratory medicine at the University of Washington. “We were told we were going to hear about the science of Theranos, [but] this is a new speculative prototype idea.”

“What we just saw was BS,” he added. “It is not the device they used clinically, and we saw nothing that tells us that these assays are valid or even safe for patients.”

John Ioannidis, a professor at Stanford University Medical School, Ms Holmes’ alma mater, said the presentation was “better than nothing,” but bemoaned the fact that the company still had not produced any peer-reviewed research.

Nanotainer tubes©Company handout

Nanotainer tubes

Dr Mike Tomasson, a professor at the University of St Louis, said one interpretation of Ms Holmes’ presentation was that the company’s earlier technology has been a “total flop, but [it] had succeeded in developing a replacement device”.

Ms Holmes conceded that the company had a “lot of work to do in building a relationship with the scientific community” and admitted that she wished she had “started earlier”.

“That is not going to happen in one day, or with one presentation,” she added.

She insisted that the company had overcome the inherent limitations of “capillary testing”, a decades-old method that involves taking a tiny sample of blood, normally from the patient’s fingertip.

Doctors and scientists have avoided the method for all but the simplest tests because of its tendency to produce unreliable results.

Copyright The Financial Times Limited 2016. You may share using our article tools.
Please don’t cut articles from FT.com and redistribute by email or post to the web.

Europe homepage

About The Author