Theranos Again Under The Spotlight After Reports Suggest It Knowingly Used Inaccurate Tests

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The media war against digital health unicorn Theranos continues, led once again by Wall Street Journal investigative reporter and Pulitzer Prize winner John Carreyrou. After years of enjoying the limelight as the darling startup of Silicon Valley, CEO Elizabeth Holmes has fought off wave after wave of Wall Street Journal-led accusations suggesting that the company’s technology produces inaccurate results and that its executives took steps to hide this from auditors. Now, the Wall Street Journal reports that new details have leaked from a still sealed inspection report of Theranos’ California lab that suggests the company also processed lab tests for patients on equipment that the company knew was generating erroneous test results.

The leaked details pertain to deficiencies found in Theranos handling of hematology tests in its Newark, California lab. CMS recently inspected the lab and found a number of serious deficiencies, including a deficiency within the labs hematology equipment that posed “immediate jeopardy to patient health and safety.” As new details emerge, it appears that this warning stemmed from the way that Theranos processed prothrombin time, or PT, tests.

PT tests measure how long it takes for blood to clot. The test is ordered on patients taking blood thinners to adjust medication doses, and is used to monitor patients at high risk of stroke. According to the Wall Street Journal, Theranos ignored quality-control data from that test that failed to meet even its own internal criteria. Between April and September 2015, “The results produced in the quality-control checks repeatedly deviated from the lab’s typical result by more than two standard deviations.”  Despite deviations that should have raised alarms within the company, Theranos continued to rely on the test, ultimately processing samples from 81 patients.

Theranos has already responded to the new accusations. Without denying the merit behind them, the company clarified that the tests in question were processed on traditional analyzers, not its own proprietary system. The company also adjusted the estimated number of patients impacted downward from 81 to 40. Last, as is becoming the norm, Theranos reiterated that the CMS inspection report reflects processes that were in place in the past, and does not reflect the current state of affairs at Theranos’ facilities.

While Theranos continues to fight what seems to be a losing battle against the media, the company is struggling to retain its existing customers, let alone sign new clients. Its largest and most prominent client, Walgreens, has been quietly working with its own legal team to find a way of ending its relationship with Theranos and having the 40 Theranos wellness centers installed in its Arizona retail centers removed.


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