December 3, 2015
By Alex Keown, BioSpace.com Breaking News Staff
PALO Alto, Calif. – Blood-testing company Theranos continues to face scrutiny following a Washington Post report that alleges the company was attempting to skirt federal law by asking a Department of Defense official to intervene in an inquiry by the U.S. Food and Drug Administration (FDA).
In 2012, the Department of Defense raised concerns about Theranos’ blood testing technology and notified the FDA. The Post reported Theranos Chief Executive Officer Elizabeth Holmes sought aid from Marine Gen. James Mattis to “squelch those ‘inaccurate’ concerns” raised by the DOD official. Theranos told the Post the Department of Defense was interested in adapting the company’s blood tests for battlefield use in a pilot program that would not have required FDA approval.
According to the Post, Mattis, who now serves on Theranos’ board of governors, sent multiple emails to other military leaders asking “how do we overcome this new obstacle.”
“I have tried to get this device tested in theater asap, legally and ethically,” Mattis wrote in the emails, the Post said. “This appears to be relatively straight-forward yet we’re a year into this and not yet deployed.”
That field test never took place, despite Mattis’ influence.
The concerns raised by the Department of Defense officials echoes concerns raised earlier this year by a Wall Street Journal report alleged that the company only performs 10 percent of its blood tests on its proprietary technology and opts to perform the majority of its blood tests using technology acquired from other companies, including Siemens . In the article, the Journal cited several former Theranos employees, as well as the medical records of patients who had used the Theranos blood test.
In addition to the concerns raised by the Wall Street Journal, which Theranos dismissed as inaccurate, the U.S. Food and Drug Administration called the company’s proprietary Nanotainer tubes an uncleared medical device in inspection reports released in October. Although the FDA’s documents are heavily redacted, federal regulators were critical of some of the practices its inspectors observed, including improper classification for its proprietary Nanotainer tubes used for blood specimens. The FDA said Theranos’ Nanotainer blood specimen tubes are not properly filed as a Class II medical device, but are instead being identified as a Class I medical exempt device. As a result, the FDA said Theranos is “currently shipping this uncleared medical device in interstate commerce between California, Arizona and Pennsylvania.” Theranos said it has “addressed or corrected all the observations at the time of, or within a week of the inspection.”
Since Theranos’ technology has come under fire, the company, which has a value of approximately $9 billion, has seen two deals fall apart. The grocery chain Safeway had plans to build $350 million worth of clinics in its stores to use Theranos’ technology tests for in-house blood testing. Safeway executives told the Wall Street Journal that Theranos missed deadlines for the blood-test rollouts and have also raised concern over the accuracy of the testing. The clinics are primarily used for flu shots and other vaccines, the Journal said.
In October, Walgreens announced it will hold off on expanding blood testing centers throughout its chain of stores until the California-based Theranos can answer allegations about the viability of its blood-testing systems, after the Wall Street Journal’s report raised questions about how accurate the blood-testing system is.
In July, the FDA approved Theranos’ systems and test for herpes simplex 1 virus. The FDA clearance includes the use of Theranos’ Nanotainer Tubes for tests run by this method, which allow samples to be collected from just a few drops of blood from a virtually painless prick of a patient’s finger.
