UPDATE: A Theranos spokeswoman confirmed to Fortune that the company voided the Edison results.
Theranos reportedly told federal regulators that it voided two years of results from its Edison blood-testing devices.
The beleaguered blood technology company told officials at the Centers for Medicare and Medicaid Services that it tossed all test results from its Edison devices from 2014 and 2015, according to the Wall Street Journal, citing anonymous sources.
Theranos has also issued tens of thousands of corrected results to doctors and patients, including those from other lab machines, and the Journal reports that several doctors’ offices in Arizona confirmed receiving corrected results in recent weeks.
Voiding and correcting so many results is a major step for Theranos, the onetime health technology darling that earned a $9 billion valuation in 2014 only to later face mounting criticism over the efficacy of its supposedly revolutionary tech. Now the company is facing the possibility of regulatory sanctions in the wake of deficiencies discovered last month at its California laboratory, after findings that its Edison devices often fell short of the company’s accuracy claims. CMS regulators proposed banning Theranos founder and CEO Elizabeth Holmes, along with president Sunny Balwani, for at least two years for not fixing major issues at the lab.
In a statement to the Journal, a Theranos spokesperson noted that “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.”
Holmes and Theranos made waves in Silicon Valley and the diagnostics industry two years ago, when investors lined up to boost the valuation of a company that claimed it would soon offer more than 1,000 varieties of blood diagnostics tests without the need for a syringe. But a now-famous Wall Street Journalreport published in late-2015 raised serious questions over the accuracy of Theranos’ claims and its proprietary technology.
