Theranos
voids two years of Edison test results: WSJ
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[May 19, 2016]
(Reuters) - 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.
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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.
"...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)
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