Founder and CEO of Theranos, Elizabeth Holmes at TEDMED 2014.
Late Thursday, federal regulators released a redacted 121-page inspection report from a Theranos facility in Newark, California, that found the company’s high-profile fingerstick blood tests failed quality checks nearly 30 percent of the time.
Theranos and its CEO, Elizabeth Holmes, made waves last year with claims that they could perform more than 200 medical tests with their Edison devices using just a few drops of blood from a finger prick — rather than a complete vein draw with a needle. With the promise that the cheap and easy fingerstick tests could revolutionize medical diagnostics, the company was valued at $9 billion.
However, since the initial buzz, the company has been hit with a series of questions, criticism and federal regulatory issues surrounding the accuracy and validity of its tests. In the latest setback, the Centers for Medicare and Medicaid Services (CMS) released a redacted inspection report that seems to substantiate the concerns and whistleblower reports about the Edison’s shortcomings.
The report, fully reviewed by the Wall Street Journal, revealed that in early 2015, Edison-based tests for a hormone related to testosterone levels failed quality checks in 87 percent of cases. A test to detect prostate cancer (measuring prostate-specific antigen, PSA) failed in 22 percent of cases. In October 2014, tests conducted by Edison for the hormone prolactin failed 47 percent of the time.
Inspectors also noted that quality control results were often erratic, test results sometimes differed dramatically from standard lab equipment results, unqualified employees performed some tests, and the company failed to notify physicians of quality control issues in a timely manner — in some cases. take seven weeks.
The performance of the Edison devices didn’t even meet the company’s internal standards. For example, Theranos procedures state that the difference between an Edison’s measurement of vitamin D in a blood sample must be equal to or less than 20 percent different from the vitamin D content of the same blood sample measured by a traditional machine. But upon inspection, the differences on nine randomly selected blood samples ranged from 21 percent to 130 percent.
“This is the first time we’ve actually seen data from the Theranos instrument, and it’s as bad as one would have thought it would be,” Stephen Master, a pathology professor at Weill Cornell Medical College, told the Associated Press. WSJ. “Based on this data, it’s hard for me to believe they went live with this instrument and tested patient samples on it.”
In a statement on its website, Theranos spokesperson Brooke Buchanan wrote that the company has “proactively” suspended some tests and is working with the CMS to address all issues. “We have made mistakes in the past at the Newark, CA lab, but when the company was made aware of the shortcomings, we devoted all resources to correcting those mistakes,” Buchanan wrote.
But the WSJ reports that the CMS is unhappy with the company’s plan and plans to impose sanctions that could range from fines to withdrawing the company’s approval to test human samples.