By Kim Smiley
The biotech startup Theranos has been all over headlines in recent years. At first the company made news for its ambitious goals of running comprehensive laboratory testing on just a few drops of blood. The company has claimed to have created a handheld medical device (nicknamed Edison) that uses only a finger prick of blood and makes blood testing less painful, faster and cheaper. Theranos’ young and compelling founder Elizabeth Holmes has been featured in multiple magazines, gave a popular Ted talk and has even been compared to Steve Jobs and Bill Gates. In 2014, the company was valued at $9 billion.
Lately, the type of headlines the company has made have changed as the company has been embroiled in controversy. The multiple concerns about Theranos can be visually represented in a Cause Map, a visual format for performing root cause analysis. A Cause Map intuitively breaks down a problem to the basic cause-and-effect relationships and visually lays them out. (Click on “Download PDF” to view an intermediate Cause Map of these issues.) Many of the issues raised haven’t been proven yet and require more evidence so a question mark is used to note this open question within the cause box.
The problems for the company started coming to a head in the latter half of 2015. A December 2015 report by The Wall Street Journal, At Theranos, Many Strategies and Snags, raised concerns about the accuracy of the company’s propriety handheld blood testing device. Studies showed that the results of the Edison device differed from testing done by traditional blood testing methods. Additionally, inspections over a three-week period in August and September 2015 at two Theranos facilities found multiple issues. Specifics on the exact problems found during the inspections have not been released, but they have been described generically as problems with record keeping, quality audits, and handling of consumer complaints. The FDA has also raised concerns about the approval of a medical device called a nanotainer that is used by Theranos. The nanotainer was classified as a Class I exempt device during the approval process and it should have been classified as a risky Class II device that would have received greater scrutiny during the approval process.
A federal criminal investigation into Theranos is now underway looking into claims the company made about its technology. A separate probe by the Securities and Exchange Commission is working to determine whether the company misrepresented its new blood testing technology and its claim that it could run a full range of laboratory tests from just a prick of blood from a finger.
As of right now, Theranos has taken a beating in the court of public opinion, but the company has not been convicted of anything and is still selling blood tests from 40 Walgreens in Arizona. Only time will tell the fate of the company, but the issues it has faced can be seen as a cautionary tale for other biotech startups. Even if the company is cleared of all wrongdoing, there are lessons to be learned about ensuring laboratories meet all appropriate standards and ensuring proper approvals of all medical devices.