Jerod Harris/TEDMED
In a new cover story for Bloomberg Businessweek, Sheelah Kolhatkar and Caroline Chen sit down with Elizabeth Holmes and some of her supporters to learn more about the the state of Theranos, her $9 billion blood-testing company.
Theranos, which promised to revolutionize the industry with tests that cost less and require much less blood, has been on the defensive since October, when an investigation in The Wall Street Journal suggested its technology had flaws and was not even being used in many cases.
At the same time, the FDA has decided the company's tiny blood vials — called "nanotainers" — need approval as a medical device, and Theranos has decided to seek clearance for 120 of its tests. (So far, only its herpes test has received FDA approval.)
That's left Theranos in a kind of holding pattern as it simultaneously waits for FDA clearance and makes promises that it will soon offer proof of its technology to the public.
"All of this," Kolhatkar and Chen write, "puts Theranos in an awkward situation." They continue:
The company has to show that it's using its own technology somehow — the whole promise of Theranos’s multibillion-dollar valuation is that its technology is exponentially cheaper and easier to use than that of existing players, and not just for one herpes test. On the other hand, if Holmes wants to hold her company to the FDA’s higher standards, as she claims, that means waiting for federal clearance on all of its tests before using them. While Theranos works its way through this transition period, it is unclear whether the company is running any tests on its own machines at all.
So what did Holmes have to say in response to this during her interview with Bloomberg Businessweek? She "refuses to answer the question," they write:
When asked if Theranos is actually running any patient samples on its own analyzers today, as opposed to devices made by Siemens or another manufacturer, she will only say, "We can run them on our analyzer, but it depends on the test order."
When the reporters followed up days later to ask again, she was still "noncommittal," explaining that tests can be analyzed on their proprietary machines or on standard machines but not specifying how they are actually run.
In October, Holmes said at a live event that Theranos was using the nanotainers only for the herpes test, but didn't specify whether the company was using proprietary analysis technology for that test or any others. It remains an open question.
Read the full Bloomberg Businessweek story here >>
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