Palo Alto, Calif.-based Theranos could face possible sanctions from the Centers for Medicare and Medicaid Services (CMS) for not fixing problems at its laboratory in Newark, California.
Citing a March 18 letter from the CMS, The Wall Street Journal reported that the company’s founder and CEO Elizabeth Holmes, and President Sunny Balwani also could be banned from the blood-testing business for two years.
Theranos was founded by Elizabeth in 2003. Since opening its Wellness Centers in late 2013, Theranos has processed over 4.1 million tests, worked with over 9,000 physicians and receives near perfect guest satisfaction ratings, according to the company’s website.
CMS is responsible for overseeing clinical labs. A letter sent by the agency to Theranos in a January states that the company’s Newark facility “pose immediate jeopardy to patient health and safety.”
Confirming receipt of the CMS’ letter, Theranos said that no sanctions have been imposed on its Newark lab yet, and the company is hopeful that CMS won’t impose sanctions because it has taken the corrective measures over the past several months.
Brooke Buchanan, the company’s spokeswoman, told the newspaper that they sent their response to the agency.
Source: The Wall Street Journal via CBS