A scientist just raised 4 serious questions about the blood test that made Elizabeth Holmes a billionaire

Theranos, a company founded by entrepreneur Elizabeth Holmes in 2003, has generated a lot of buzz for developing a revolutionary approach to the blood test.

Theranos’ innovation theoretically does clinical lab testing faster, cheaper, and, in some ways, better. Because of that, their technology threatens to upend the branch of medicine that provides the data used in roughly 70% of medical decisions.

That disruptive potential has already made Theranos famous and Holmes, who left Stanford University as a sophomore to chase her dreams, the youngest female billionaire in the US. But the more attention Theranos gets, the more questions people ask.

A recent editorial in the journal Clinical Chemistry and Laboratory Medicine questions just how innovative the Theranos technology really is. The author, Eleftherios P. Diamandis, the head of clinical biochemistry at Mount Sinai Hospital in Toronto, argues that “most of the company’s claims are exaggerated.”

Most of Diamandis’s scepticism stems from the same fundamental concern that other researchers have voiced: without seeing studies that dissect Theranos’s seemingly revolutionary test, he can’t know just how good it might be.

“History teaches us that there are numerous examples of seemingly disruptive technologies in healthcare (and especially in diagnostics) … which later collapsed, due to their inability to deliver the promised goods,” he writes, noting that the merits and quality of the Theranos technology in particular are difficult to judge. The company hasn’t published details of how their technology works in scientific journals. They have received certification to operate as a lab and partnered with hospital systems, who have inspected the technology, but the specifics about how it works haven’t been made public.

The company has consistently said the FDA is the “gold standard” for evaluating a medical test, and that they want to be evaluated by that administration without giving up proprietary information on how their technology works. While Theranos did not offer Business Insider a specific response to Diamandis’s editorial, they have addressed some of the points herein with us already.

Still, Diamandis highlights four areas where Theranos says it is innovating, but where he argues — based on his knowledge of existing technologies — that they are not: in the speed of test results, the cost of blood tests, the painfulness of blood tests, and the delivery of results directly to patients.

1. Speed. Diamandis says the company highlights the fact that their tests take just a few hours. But he writes that “the bulk of laboratory testing in centralised laboratories is completed within an hour or two,” with some exceptions in the kinds of tests needed by chronically ill patients. That would mean that for the vast majority of patients, Theranos does not actually offer much of an improvement on speed. However, the fact that Theranos delivers results to patients within hours may be the main difference in speed between the company and traditional labs. They may be able to run tests at similar speeds, but don’t communicate results to patients as fast.

2. Cost. Diamandis argues that Theranos’s tests may not actually be cheaper than traditional ones, since the cost to a centralised lab is already incredibly cheap (less than a cent for many common tests). That may be true, but when Theranos talks about their tests being cheaper, they don’t mean their own costs. They focus on the fact that they actually charge consumers and groups like Medicare much less than traditional labs — something they show by posting the prices for their tests online, and something that probably matters more to consumers.

But if most of the expense to consumers is due to overhead and personnel at centralised labs, as Diamandis states, and if Theranos has figured out a way to simplify and streamline those aspects of the operation, that — along with unverified improvements to the testing technology itself — may help explain why they can offer prices as cheap as they do.

3. Pain. Most blood draws are collected from a vein, often in the crook of your arm. Theranos uses a fingerprick instead — something that seems less scary but some argue is less foolproof, as we previously reported. “If the prick is not done properly (deep enough), the sample will consist mostly of interstitial fluid instead of blood,” Diamandis explains, which means sometimes multiple fingerpricks are needed. And even though they seem less scary than a larger blood draw (Holmes herself has said she is afraid of needles), they may not be more comfortable: Diamandis cites some anecdotal reports that describe the pain as greater and longer-lasting.

4. Direct-to-patients results. “The current wisdom suggests that testing should be ordered only when there is a question to be addressed and the result of the test will aid in an intervention that will be useful to the patient,” Diamandis writes. That goes against one of Holmes’s key philosophies, and a founding tenet of Theranos: that patients should be able to be more in control of their own health data, ordering blood tests for themselves and seeing their own results. But while that seems appealing, our current ability to interpret such data means that overtesting often results in confusion and unnecessary treatment.

After running through these four points, Diamandis concludes his argument by suggesting that Theranos’ “claims of superiority over current systems and practices are speculative, at best.

He also reiterates that it’s hard to judge a technology when the details are kept secret. That’s a problem not only with Theranos, but with a growing cadre of biotechnology companies.

“Stealth research creates total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcements, and mass media hype,” argued the renowned Stanford doctor John P. A. Ioannidis in a recent issue of the Journal of the American Medical Association. “How can the validity of the claims made be assessed, if the evidence is not within reach of other scientists to evaluate and and scrutinize?”

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