- In 2012, a Department of Defense official flagged Theranos' proprietary blood-testing technology for possible violations of federal law. Theranos' claimed its blood-test could obtain results from a single finger-prick of blood. The DOD had reviewed the tests for military research exploring the feasibility of porting the finger-prick testing to combat situations.
- The military official investigating Theranos' technology reportedly grew concerned about a lack regulatory compliance.
- In response to the inquiry, CEO Elizabeth Holmes attempted to quell the investigation, calling the military reviewer's information "blatantly false." She even appealed to four-star Marine General James Mattis, who Holmes had met a year prior at a DOD event. Mattis now sits on Theranos' Board of Directors.
Prior to this fall, Theranos had been hailed as a hot start-up with immense potential in its unique blood-testing technology. In theory, Theranos offered more than 240 tests using just a finger-prick of blood, including tests for everything from pregnancy, to potassium levels and thyroid, to cancer and cholesterol.
In practice, its primary testing device, known as Edison, has handled a relatively small percentage of the tests. Instead, most testing relied on traditional machines. A deal with Safeway subsequently fell apart when it become apparent Theranos was not offering reliable blood-testing services. In addition, Walgreen's backed away from expansion of an existing deal with Theranos, as more information came out about lack of FDA clearance for all tests using Edison (except the herpes test). Some, including Safeway executives, began to question whether the finger-prick approach actually yielded accurate results.
This new report of attempted intervention into a DOD inquiry only darkens the storm clouds around the troubled company. Holmes apparently was calling in favors with Mattis. Despite the general's enthusiasm and support, the Department of Defense does not currently use Theranos's blood-testing technology in any combat theater.
Theranos has been fighting back, however. Even as its reputation falters, the company has cast any criticism of its technology or approach as misleading.