Theranos Inc. The company claimed that it had devised blood tests that required very small amounts of blood and that could be performed rapidly and accurately, all using compact automated devices that the company had developed. These claims were proven to be false. A turning point came in , when medical research professor John Ioannidis , and later professor of clinical biochemistry Eleftherios Diamandis , along with investigative journalist John Carreyrou of The Wall Street Journal , questioned the validity of Theranos's technology.
The company faced a string of legal and commercial challenges from medical authorities, investors, the U. While at Stanford University , Elizabeth Holmes had an idea to develop a wearable patch that could adjust the dosage of drug delivery and notify doctors of variables in patients' blood. After many missed deadlines and questionable results from a trial clinic at Safeway's corporate offices, the deal was terminated in In November , it filed a suit against Theranos in federal court in Delaware for breach of contract.
In March , the Cleveland Clinic announced a partnership with Theranos to test its technology and decrease the cost of lab tests. In February , Stanford professor John Ioannidis wrote in the Journal of the American Medical Association that no peer-reviewed research from Theranos had been published in medical research literature. Vice President Joe Biden to tour their facility. Biden praised what he saw, [ 38 ] but to conceal the lab's true operating conditions, Holmes and Balwani had created a fake lab for the Vice President's tour.
In October , John Carreyrou of The Wall Street Journal reported that Theranos was using traditional blood testing machines instead of the company's Edison devices to run its tests, and that the company's Edison machines might provide inaccurate results.
Secretary of State George P. Shultz , was a key source for the WSJ story. Shultz had attempted to take his concerns to company management. Theranos claimed that the allegations were "factually and scientifically erroneous". Department of Defense in , when the devices were not yet commercially available and therefore did not require FDA approval. Theranos asserted that the nanotainer was a Class I medical device and therefore not subject to any regulatory requirements.
