Theranos has gotten only one test cleared by the FDA. That test – for Herpes infection – is for the detection of antibodies, not a measurement of their concentration. Tests for the presence or absence of a molecule are much simpler than those that quantify its concentration.
In March, researchers at the Mount Sinai School of Medicine published a secret shopper study comparing Theranos to Quest and LabCorp, two major medical testing companies. Overall, more of the results from Theranos were outside the normal range, indicating a need for further medical testing. This is a worrisome result because the secret shoppers were healthy adults. But it’s also difficult to interpret because we don’t know if Theranos used its Edison machines or ran diluted samples on conventional analyzers.
Millions invested without any proof?
Why didn’t investors and journalists dig more deeply, such as by demanding a head-to-head comparison of Theranos’ Edison machine to standard chemistry analyzers?
Part of the problem seems to have been the secrecy surrounding these types of startups. Theranos always asserted that it had to operate in “stealth mode” to protect its lead in breakthrough technology, which means that there was literally no peer-reviewed information out there about its technology.
But the leading explanation seems to be that they were enthralled by the company’s charismatic young founder. Laudatory magazine cover articles about Holmes have been so numerous that the phenomenon has itself been a topic of discussion.
Theranos’ board of directors also lacked anyone with expertise in laboratory testing or medical diagnostics. This should have been a warning sign.
Show me the data
Just a few weeks before regulators proposed banning Holmes and Theranos President Sunny Balwani from the blood-testing industry, the company tried to remedy this by bulking up its medical advisor board with well-qualified experts in chemistry, pathology and clinical chemistry.
It’s hard to imagine these experts would have signed on amid all the bad publicity and allegations without demanding proof that the technology works, but who knows?
It still remains possible that Theranos has discovered a breakthrough technology that can do hundreds of lab tests on a drop of fluid from a patient’s finger. But even if this increasingly unlikely prospect is a reality, Holmes’ erstwhile acolytes need to remember the lessons learned from the pantheon of past pied pipers and summed up by statistician W. Edwards Deming:
In God we trust; all others must bring data.
This article originally appeared on MPR