On June 3, Elizabeth Holmes, the founder and CEO of Theranos, a company that developed a revolutionary blood test that relies only on a drop of blood, appeared on Charlie Rose‘s show to talk about her company and in theory, about some of the science behind it.
But the essential question about Theranos’s technology remains unanswered after the segment: How exactly does what Holmes invented work?
Theranos’s technology sounds transformative. Holmes’s new blood test only needs a few drops of blood, which can be drawn from a fingerprick, and dozens of tests can be performed using that tiny quantity of liquid, all for far cheaper than what a traditional lab or a hospital would charge.
The company, however, is renowned for their secrecy, and instead of allowing independent experts to assess how their technology works, they have declared that they want the Food and Drug Administration (FDA) to evaluate their technology instead.
There’s nothing inherently wrong with this — as Holmes said to Rose last night, historically, labs have been able to use any tests they create themselves without any oversight, and Theranos designed their own tests. They have also publicly called for the FDA to start evaluating these lab-developed tests, including and starting with their own.
But Theranos’s invention is a huge departure from traditional testing, and before doctors decide to use a new medical innovation, they want to see proof that it actually does what its creator says it does. Theranos has partnered with existing hospital and research organisations as well as pharmaceutical companies, who have presumably seen and accepted their data — but it’s still not public information.
Experts from the American Association for Clinical Chemistry and the University of Chicago (among others) told Business Insider for a prior story that the thing that would convince them that Theranos’s tests work as advertised would be peer-reviewed studies comparing these innovative blood tests to traditional ones. The reason they want to see that data is because this new test seems so transformative, and therefore, potentially useful.
Dr. Jerry Yeo, a professor and director of Clinical Chemistry Laboratories at the University of Chicago, asked: “Why haven’t they shown us that information, why haven’t they been willing to publish it, and why haven’t they shown comparisons with existing technology?”
Theranos doesn’t want to reveal what they consider proprietary information to their competitors, and their response has always been that they want the FDA to assess whether or not their tests are effective.
Holmes re-iterated that position last night, and said the same thing that a Theranos spokesperson told Business Insider: They believe the FDA is the “gold standard” for evaluating a test, and that’s the route they want to go.
Holmes told Rose that it’s really just the major lab companies — presumably Quest and LabCorp, the two main companies that do clinical testing in the US — that question whether or not her invention actually works.
Theranos could completely disrupt those companies’ businesses, and they have indeed asked those questions. But independent experts that we spoke with have also said they want to see Theranos’s data, as have experts like Lakshman Ramamurthy, a molecular biologist and a former associate director at the FDA, who spoke to the New Yorker’s Ken Auletta.
These experts aren’t negative about Theranos. They think the company has a ton of potential and what they’re doing could be a huge development for medicine. They just have questions they want answered before they’re willing to say, “yes, this works.”
But no matter who is asking, Holmes told Rose that whenever they decide to disclose more information it will be their decision. “It shouldn’t be reactive,” she said.
Theranos has a fascinating story and Holmes seems like a brilliant innovator, but it seems we’ll have to wait for the FDA before we can tell the full story.
Rose asked Holmes when that would be.
“We’ve been working on it,” she said, but then added: “I’m the last person who should be predicting when the FDA clearance will come.”
Check out the Charlie Rose conversation here.
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