(Bloomberg) -- Blood-testing startup Theranos Inc. said it sent doctors andpatients tens of thousands of corrected test results and voided twoyears of data from its devices, a devastating blow for the companythat has come under scrutiny over the accuracy of itstechnology.
|Read: Theranos CEO: Consumers deserve better accessto blood testing
|The Silicon Valley startup told federal healthregulators at the Centers for Medicare and Medicaid Servicesthat it had voided results from 2014 and 2015 generated by itstesting devices, the Wall Street Journal reported. Theranosspokeswoman Brooke Buchanan confirmed the report by e-mail.
|“Excellence in quality and patient safety is our top priorityand we’ve taken comprehensive corrective measures to address theissues CMS raised in their observations,” Buchanan said in ane-mail. “As these matters are currently under review, we have nofurther comment at this time.”
|Read: How testing workers genes could make wellnessprograms work
|Lauren Shaham, a spokeswoman for CMS, declined to comment.
|Theranos is developing a technology that, the company has said,can run scores of diagnostic tests using only a few drops of blood.The Palo Alto, California-based startup has faced questions aboutwhether its technology works and has been subject to investigationsby the U.S. Securities and Exchange Commission, the U.S. Attorney’sOffice in San Francisco, and federal and state healthregulators.
|President and Chief Operating Officer Sunny Balwani left thecompany last week, saying he was retiring. At the same time,Theranos reconfigured its board, adding former Amgen Inc. executiveFabrizio Bonanni.
|Theranos’s business has grown mainly through its partnershipwith Walgreens Boots Alliance Inc., with about 40 of its testingcenters placed in Walgreens outlets in Arizona. Walgreens spokesmanMichael Polzin declined to comment on whether the drugstore chainwould continue working with Theranos.
|Copyright 2018 Bloomberg. All rightsreserved. This material may not be published, broadcast, rewritten,or redistributed.
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