As a slightly more upbeat follow-on to the Wall Street Journal’s blistering exposé of Palo Alto diagnostics startup, Bloomberg has written a lengthy feature on whether CEO Elizabeth Holmes can “save her unicorn.”
It’s still up in the air. Holmes is determined to keep Theranos afloat, and make that single-blood-drop technology come to validated fruition. And Holmes, on the surface, is finally espousing the idea of cutting the talk and showing what Theranos is actually made of, as she says to Bloomberg:
“What we need to do now is focus on the technology and focus on the science and the data and put that out there,” Holmes says. “Because that speaks for itself.”
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But the company is still staying hush about its internal operations. One of Theranos’ biggest criticisms was whether it ran its single-blood-drop samples on machines developed in-house, or on commercial lab equipment.
But when pressed for detail, Holmes remains murky as ever. As Theranos waits to receive FDA clearance for its battery of some 120 diagnostic tests, it remains questionable whether the company is running tests on its own equipment or on standardized lab equipment. Bloomberg writes:
Holmes refuses to answer the question. 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.”
A few days later, when she’s asked again, her response is still noncommittal: “Depending on the order, it can happen on the TSPU, with our chemistries, and it can happen on conventional machines, just using traditional venous draw.” It can. But is it? She points out that other labs don’t publish such information, which is true. But then, other labs don’t usually declare themselves medical revolutionaries.
Bloomberg writes:
Holmes says the company’s era of secrecy is over, and it’s inviting outsiders, including reporters, to try the tests for themselves. (For the record, the finger prick feels like a finger prick.) In December, she says, a group of independent medical experts will spend two days in Theranos’s lab to examine the technology, the data, and the regulatory filings, and can then talk publicly about what they found. The Cleveland Clinic is running a study comparing Theranos’s results with traditional blood draws and will publish the findings. Holmes is also putting together a medical advisory board that will bring more scientific and regulatory expertise. She says Theranos is preparing “manuscripts” containing the testing data that’s been submitted to the FDA, which it plans to publish in a medical journal (she won’t say when or which journal). Its main competitors, Quest and LabCorp, have done no such thing, she points out.
There’s a reason that Theranos shot to prominence, and it isn’t just because Holmes is “a young woman.” The underlying single-drop-of-blood technology could actually be revolutionary – and Holmes has every intention to keep at it until it works.
Dr. Waldo Concepcion, chief of clinical transplantation surgery at Stanford University Medical Center and a newly onboarded consultant for Theranos, said that despite the potential lack of accuracy of the tests, from looking at the company’s he’s “encouraged” that they could actually work.
“Does it work?” he said to Bloomberg. “And if it does not work, can we tweak it until it does work?”
But the recent negative attention is propelling customers to test themselves at Theranos’ wellness centers in Arizona, Holmes says.
“I mean, is it incredibly painful to see people say this kind of stuff about us? Of course it is,” she says. “But is it a crisis? No. We’ve built something that’s incredible, and we have now the opportunity to showcase it.”
