Theranos: ‘Failures in nearly every aspect of laboratory operation’

Theranos continues to boost its status as one of history’s most disastrous startups, as another report has arrived concerning shortcomings in the Palo Alto firm’s blood testing and operations.

The firm, once touted by founder Elizabeth Holmes as revolutionary in blood testing for disease, is itself on life support after regulators found problems with testing in its Arizona laboratory.

In July, Theranos was stripped of its license to run a laboratory in California and Holmes was banned for two years from involvement in the business of blood testing. The firm, which announced in January it would lay off 41 percent of its workforce, said it would appeal those decisions. Theranos is also reportedly facing a criminal investigation over whether it deceived investors.

On Wednesday, the Wall Street Journal reported that Theranos’ lab in Arizona didn’t make sure some patients who may have received inaccurate diabetes test results were notified of the possibly false results; that it did blood-coagulation tests on an improperly configured machine; that it neglected to verify the accuracy of tests used to determine cholesterol levels; and that it fell short on testing related to prostate cancer screening.

The newspaper’s story was based on a report it obtained through a public-records request.

The report found “failures in nearly every aspect of laboratory operation,” Sten Westgard, director of client services and technology for Westgard QC, a firm that develops lab-quality guidelines, told the Journal.

Theranos closed the Arizona lab about a week after inspectors had visited, according to the newspaper. It conceded in a statement to the Journal that “several deficiencies in the Arizona lab were cited that could have affected the accuracy of the test results generated by that laboratory.”


Photo: Theranos CEO Elizabeth Holmes in 2014. (Karl Mondon/Bay Area News Group)


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