Theranos CEO Elizabeth Holmes banned from running lab for 2 years
In a statement issued late Thursday, Theranos announced that it had received notice from the US Centers for Medicare and Medicaid Services (CMS) that it is facing severe sanctions.
According to a press release, the Centers for Medicare & Medicaid Services (CMS), a government health agency, also revoked the company’s CLIA certificate for its Newark, California lab.
CMS subsequently launched an investigation into the company’s lab in Newark, California.
Former U.S. President Bill Clinton speaks as Elizabeth Holmes, founder and CEO of Theranos, listens during the closing session of the Clinton Global Initiative 2015 in New York City, Sept. 29, 2015.
Last week, a congressional committee issued a letter to Holmes and the company seeking information on the company’s failure to comply with federal clinical laboratory testing standards as well as the company’s decision to void two years’ worth of data sent to customers.
Theranos and in turn, Holmes, have been making headlines for quite a while now due to concerns over the legitimacy of blood tests from Theranos-owned and operated labs. The company was also given a list of corrective measures. The company apologized for the mistakes and promised to fix them.
Theranos was perhaps the most celebrated of these young companies. That same device and its testing method became the center of a controversy following a Wall Street Journal report a year ago.
The company collected the small blood samples with vials called nano trainers, yet the FDA hadn’t approved the use of the vials.
Since CMS first indicated sanctions could be forthcoming, Theranos’ ongoing problems have intensified sharply. However, not all is lost for the founder, as Theranos can still appeal to an administrative law, followed by a departmental appeals board. Several Journal articles began to raise questions about the accuracy of the startups technology used on patients and CMS declared the company was putting patients in “immediate danger”.
It is unclear what the company’s future will be, especially with Elizabeth Holmes being unable to “own, operate or direct a lab”.