Theranos voids two years of Edison test results: WSJ
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Blood-testing firm Theranos Inc notified the U.S. federal health regulators that it voided results from its Edison blood-testing devices for two years, the Wall Street Journal reported on Wednesday, citing a person familiar with the matter.
The company informed the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors and patients, nullifying some results and revising others, the Journal reported, citing a person familiar with the matter.
The corrected reports include the Edison results and many tests run on traditional laboratory machines, the Journal said.
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"...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," a Theranos spokeswoman said in an email.
In April, U.S. federal health regulators had proposed banning the company's founder, Elizabeth Holmes, from the blood-testing business for at least two years after determining that the company failed to fix deficiencies at its California laboratory.
The blood-testing firm which expanded its board to include Dr. Fabrizio Bonanni, a former Amgen Inc and Baxter International Inc executive, has been under investigation by several U.S. regulators in the recent past.
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Centers for Medicare and Medicaid Services was not immediately available for comment.
(Reporting by Vishal Sridhar in Bengaluru; Editing by Sunil Nair)