Blood-testing firm Theranos has appointed a new chief compliance officer and a new vice president for regulatory and quality to handle its regulatory issues, the Wall Street Journal reports.
Centers for Medicare & Medicaid Services officials recently rescinded the firm's license to operate its California lab and banned CEO Elizabeth Holmes from owning or operating a clinical lab for at least two years. That ban won't go into effect just yet, as the company can appeal the sanctions, but the Journal previously noted that legal experts and government data indicate that its chances of overturning the decision are "slim."
Theranos hired Daniel Guggenheim, formerly an assistant general counsel for regulatory law at the healthcare distributor and information-technology provider McKesson Corp., as its chief compliance officer. In a statement, the company says Guggenheim will lead and oversee the implementation of Theranos's compliance program.
Meanwhile, it named Dave Wurtz, who served as senior director of regulatory, quality, and compliance at Thermo Fisher Scientific, as its vice president of regulatory and quality. He will oversee the company's bid to obtain clearances and approvals from the Food and Drug Administration as well as market new products and manage the company's regulatory affairs, medical device quality systems, and clinical affairs teams.
The Journal adds that the Theranos board of directors has also created a compliance and quality committee.
The company says these are "latest in a series of significant actions Theranos has taken to ensure that it meets the highest standards in its laboratories, medical products and operations."