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Federal health officials may ban Elizabeth Holmes, founder and CEO of blood-testing start-up Theranos, from owning or running any labs for at least two years, The Wall Street Journal reported Wednesday.
The move comes after the company failed to fix "major problems" at a California lab, according to a letter from the Centers for Medicare and Medicaid Services (CMS) obtained by the Journal. If any sanctions are enacted, a lengthy appeal process would be involved, according to the newspaper.
Theranos spokeswoman Brooke Buchanan told CNBC she was hopeful that CMS would not impose sanctions, as the company works on comprehensive corrective measures, including the recent recruitment of an advisory board of scientific and medical experts.
"But if they do, we will work with CMS to address all of their concerns," Buchanan confirmed to CNBC.
Theranos became famous for fast, accurate and affordable blood testing using smaller needles and tubes.
But the company, valued at more than $9 billion, has come under scrutiny after media reports questioned the accuracy of the proprietary test methods, the Journal said. A particular blood-coagulation test was deemed by health officials in January to put patients in "immediate jeopardy," according to the newspaper's report.
The company has told the Journal it doesn't believe any patients were affected.
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