Federal Report Reveals Theranos Devices Often Failed Accuracy Requirements

Federal Report Reveals Theranos Devices Often Failed Accuracy Requirements
April 1, 2016
By Alex Keown, BioSpace.com Breaking News Staff

PALO ALTO, Calif. – Bad news keeps coming for privately held Theranos. A scathing government report shows Theranos’ Edison blood testing devices has failed to meet the company’s own standards, the Wall Street Journal reported this morning.

The U.S. Centers for Medicare and Medicaid Services (CMMS) released a 121-page report of its findings following a series of inspections at Theranos’ Newark, Calif. lab and the news for the company valued at $9 billion based on its proprietary blood-testing is not good. The CMMS report showed 29 percent of quality control checks performed on Theranos’ Edison devices in October 2014 “produced results outside the range considered acceptable by Theranos,” the Journal reported. A February 2015 test using the Edison device to measure testosterone levels failed quality control checks 87 percent of the time. The CMMS report shows several months-long stretches of quality control issues when it comes to the Edison device.

Other issues at the lab which conducted approximately 890,000 annual tests include storing blood samples at the wrong temperature, delays in notifying patients of flawed test results and having unqualified personnel working at the lab, the Journal said.

In a statement on the Theranos’ website, Brooke Buchanan, Theranos’ vice president of communications, said the company has dedicated every resource to make corrections to the Newark lab. She noted several course corrections the company has made to the lab, including personnel changes, the adoption of “enhanced “quality systems, policies and procedures” and the suspension of some testing at the Newark site. Buchanan said the company has also “voided results associated with any findings that were not consistent with the quality standards the lab holds itself to today, under our lab’s new leadership.”

Buchanan said the issues discovered by the CMMS at the Newark site has made Theranos a more improved company. Those actions may not be enough for CMMS, the Journal said. Citing “people familiar with the matter,” the Journal said the agency may impose sanctions against the company.

The full CMMS report comes on the heels of a new study of its technology which raises more questions about the accuracy of the company’s single-drop blood tests. The study, published in the “Journal of Clinical Investigation” and conducted by the Icahn School of Medicine at Mt. Sinai, compared Theranos’ blood-testing methods to more traditional testing methods of larger companies Quest Diagnostics and Laboratory Corporation of America Holdings . While some blood tests were comparable, the study showed Theranos’ reporting of cholesterol and white blood cell counts was more likely to show abnormal results as the more traditional testing conducted by those other companies. The researchers said Theranos was 12.5 times more likely to say it could not get results from a sample when it came to cholesterol levels. Theranos testing was 60 percent more likely to report levels were too low or too high.

The study, combined with the concerns raised by the full CMMS report has raised concerns at Walgreens, which partnered with Theranos to provide blood testing at 40 of its Arizona stores. Walgreens has toyed with the notion of suspending its relationship with Theranos based on some of the negative criticism the company has received and concerns over accuracy of the tests. Citing an anonymous source, Fortune said Walgreens is “in the process of assessing this latest development.”

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