The controversial blood-testing company Theranos has voided two years of results and issued tens of thousands of corrected reports, further undermining its credibility and raising serious questions over its future.
The discarded results were run both on traditional testing machines and on Theranos' "revolutionary" Edison machines, whose claimed efficacy was behind a $9bn valuation of the Silicon Valley company.
However, Theranos admitted to regulators that not one of its tests carried out on the Edison machines in 2014 and 2015 stand, and all have been corrected.
The news, broken by The Wall Street Journal, lends yet more weight to the paper's earlier report that claimed the Edison machines were unreliable and the company was using traditional testing machines for most of its work. Soon after the report came out, the company stopped using its special machines altogether.
The massive correction of tests – which have impacted doctors and patients across the United States – is unprecedented and just the latest effort by the company to avoid official censure by health regulators the Centers for Medicare and Medicaid Services (CMS). The CMS has threatened to shut down the company's California testing facility and ban Theranos CEO Elizabeth Holmes from running such a facility for two years over "serious deficiencies" that it had found.
Not so sunny
Earlier this month, the company announced that its president and chief operating officer Sunny Balwani was "retiring," in a move widely seen as an attempt by Holmes – who owns 50 per cent of the company – to stay in her job. The CMS will shortly make a final decision on whether to impose sanctions against Theranos.
Last month, Theranos admitted it is also being investigated by the US Securities and Exchange Commission (SEC) and the US Attorney's Office over claims it misled investors and government officials.
The Wall Street Journal tracked down a number of doctors' practices that had been impacted by the corrected reports, and gave one example of a doctor sending a patient to the emergency room due to abnormally elevated test results. The corrected report showed that the levels were in fact perfectly normal.
On top of having lost credibility with the medical profession, the bulk of Theranos' work may also dry up if Walgreens decides to go through with its threat to end its relationship with the company if the health regulator does not give the company a green light.
A Theranos spokeswoman told the paper in response to its questions: "Excellence in quality and patient safety is our top priority and we've taken comprehensive corrective measures to address the issues CMS raised in their observations. As these matters are currently under review, we have no further comment at this time."
Meanwhile the name Theranos has itself become a byline for a tech company that misleads people over what its technology can do. ®