Theranos has been getting it from all sides lately, with the FDA coming down on the company for running its proprietary testing tool as an uncleared medical device and numerous reports calling its testing methods into question. Now Theranos is facing more scrutiny, as a new report shows that the company asked a military general to squelch unsavory information about its testing from the U.S. Department of Defense (DOD).
Back in 2012, an official evaluating Theranos' blood-testing technology for the DOD launched a formal inquiry with the FDA about the company's plans to distribute its tests without FDA clearance, according to emails seen by The Washington Post. The military approached Theranos about using its blood tests in the battlefield after Theranos CEO Elizabeth Holmes met four-star general James Mattis at a Marine Memorial event. Mattis, who was overseeing war in Afghanistan at the time but has since retired, told Holmes that he wanted to test Theranos' technology in combat areas.
"I've met with my various folks and we're kicking this into overdrive," Mattis wrote to Holmes in June 2012, according to the Post story. "I'm convinced that your invention will be a game-changer for us and I want it to be given the opportunity for a demonstration in-theater soonest."
But things didn't shake out that way. A military regulatory expert contacted the FDA with concerns about Theranos' technology without telling the company first, stalling the project and prompting Holmes to reach out to Mattis for help.
"I would very much appreciate your help in getting this information corrected with the regulatory agencies," Holmes wrote in an email to Mattis, saying that since the "misinformation came from within DOD, it would be "invaluable" to have the information "formally corrected by the right people in the DOD."
Mattis forwarded the exchange to military officials, asking "how do we overcome this new obstacle," the Post reports. But the field demonstration that Mattis requested never occurred.
In July 2015, Mattis ended up joining Theranos' board of directors after he retired from the Marine Corps, but faced a restriction. A defense department counsel told Mattis that he could not discuss the potential pilot test of Theranos' device in Afghanistan in front of the DOD or Department of the Navy as long as he was on the company's board.
|Theranos CEO Elizabeth Holmes|
Theranos is standing by its military dealings, telling the Post in statement that the pilot research project would not have needed standard regulatory approval. And Mattis only has kind words for the company, saying that he saw "tremendous potential" in Theranos' technologies and that he has "the greatest respect for the company's mission and integrity."
But questions about Theranos' technology abound after The Wall Street Journal published reports in October about its testing. Theranos, which got FDA approval for its finger-stick herpes test in July, stopped collecting finger-prick blood samples for all of its other tests after the FDA said that "nanotainers" manufactured and used by the company to collect sample were unapproved medical devices. Another report showed that Theranos was doing most of its testing on devices made by other companies.
The news sparked the ire of consumers, lab experts and some of Theranos' partners. Walgreens Boots Alliance ($WAB), one of the company's top partners, said that it won't open any new Theranos blood-testing centers in its stores until the startup answers questions about its technology. Last month, Safeway ($SWY) called off its $350 million deal with Theranos, handing a win to the company's rival Sonora Quest, which has been gaining ground with its DTC testing services.
- read the Washington Post story
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