In October, Theranos' founder told a crowd at a conference sponsored by the Cleveland Clinic that it would let outside researchers from the clinic study its inventions — and publish their results. Days later, Cleveland Clinic CEO Toby Cosgrove told CNBC that the clinic was interested in verifying Theranos' technology (Theranos and the clinic are partners). But those statements haven't turned into tangible actions. Theranos told Fortune on Monday night that the startup hasn't even started thinking about when the study should commence.
"It takes time to get these studies in place," Theranos spokesperson Brooke Buchanan told Fortune. "We should know in the coming months."
"We never said we were going to do it before."
And even though Theranos founder Elizabeth Holmes told Bloomberg Businessweek in December that her company was preparing study manuscripts for publication in a medical journal, the startup has no immediate plans to publish them. More specifically, Theranos refuses to publish anything that might help validate its tests before it gains approval for its tests from the FDA; Theranos has submitted more than 120 of its tests to the regulatory agency. "Once we get them back they’ll be published, but not before," Buchanan says. "We never said we were going to do it before."
Given that Theranos currently has one approved test, using the FDA as a shield to ward off publication of a study seems ridiculous. But Theranos' desire to conserve its trade secrets isn't just another example of the ruthlessness of Silicon Valley startups; we may soon find out that it enabled risky practices at the company's Newark, California lab. Last week, Theranos received a letter from the US Centers for Medicare and Medicaid Services that suggested that the way Theranos was studying blood cells at the lab posed "immediate jeopardy to patient safety." Because the full lab inspection report has yet to be released, it's unclear if the deficiencies identified by CMS inspectors are related to Theranos' inventions or to the machines that Theranos bought from other manufacturers. But if Theranos' inventions or proprietary tests are to blame, the fact that the startup has repeatedly dodged opportunities to validate its inventions may put the company in even hotter waters.
Update February 2nd, 5:39PM: Theranos contacted The Verge after this story was published to tell us that the startup will be holding a "roundtable" in February or March during which the company will invite outside researchers to look at their technologies and report on the meeting publicly. The roundtable will also include staff from a medical journal that will be given the opportunity to write about the company. Whatever is written will not consist of a peer-reviewed study, however. And Theranos hasn't picked which medical journal will be invited. "We are narrowing that down," Buchanan says.