Spoiler warning in case you don't want to know how the movie will probably end: the Wall Street Journal reports US regulators have devised to ban the owners and operators of Theranos from running a lab for two years. That includes CEO & founder Elizabeth Holmes, as confirmed by a press release issued tonight. The Centers for Medicare & Medicaid Services (CMS) revoked the lab's Clinical Laboratory Improvement Amendments (CLIA) certificate and imposed a civil money penalty for an unspecified amount.
We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions. Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures.
While we are disappointed by CMS' decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance.
The ban does not take effect for 60 days, however Theranos says it will not do any testing at the Newark, CA lab CMS investigated, and instead will serve customers from its lab in Arizona. Questions about the company's ability to accurately perform blood tests have swirled since the WSJ reported late last year that the FDA was investigating. Since then the company has voided thousands of past test results, and last month Walgreens formally ended their partnership.