Ana Santos Rutschman | Saint Louis University
One of the most high-profile trials of the year is underway to decide whether Theranos founder Elizabeth Holmes defrauded patients and investors.
Her blood testing startup, once valued at almost US$10 billion, was based on a seemingly revolutionary premise. Company executives promised investors, and later business partners and patients, that their technology could run hundreds of tests off a single drop of blood. It could not.
While the ongoing trial focuses on the specific wrongdoings of Theranos and Holmes, as a researcher on health technology regulation I believe it also offers an important cautionary tale about problems with how certain medical devices are made available to patients in the United States.
The story of Theranos
Holmes founded the company that became known as Theranos in 2003 with a plan to develop a new blood testing technique.
The technology was two-fold: It involved a device called a nanotainer, which was used to collect blood through a finger prick. The blood would then be tested by another device, called the Edison. Theranos claimed that it could perform a wildly large number of tests, such as measuring glucose levels and detecting different types of antibodies, or even marijuana and opiates.
Despite a lack of transparency about how the technology actually worked, investors poured money into the company, which made its tests available to patients in 2013, including through a partnership with Walgreens.