Theranos continues to be full of surprises. After the Centers for Medicare and Medicaid Services hit the blood testing business with sanctions, which included revoking the company’s license to operate its Newark, California laboratory, the company issued a statement that it plans to appeal to re-open the lab.
In January, a letter stated that Theranos’ lab practices “pose immediate jeopardy to patient safety,” and gave Theranos 10 days to correct those practices. Theranos protested those sanctions even then in a statement, saying the survey of the Newark lab didn’t reflect the current state of the lab, that it had addressed many of the observations and was actively taking corrective action.
In its latest statement Theranos wrote:
Theranos is not conducting patient testing at its Newark facility. In addition, since CMS originally announced the imposition of sanctions, Theranos has made substantial progress toward correcting the deficiencies CMS identified, including appointing new laboratory leadership; enhancing Theranos’ clinical policies and procedures; and revamping training programs.
While the appeal is pending, Theranos intends to continue communicating with CMS regarding the possibility of reaching a mutually agreeable resolution to this matter.
The company had hinted it would appeal the sanctions last month. Given the steady stream of bad news hitting the company this year, from a ban preventing CEO Elizabeth Holmes from running a clinical lab for two years to Walgreens ending its partnership with Theranos, it’s a little surprising that Theranos continues to fight for survival. Even with the long-anticipated appearance at the American Association for Clinical Chemistry Annual Scientific Meeting earlier this month, Holmes declined to offer any significant new data on the company’s blood testing technology and instead previewed a new product. It also submitted a test for the Zika Virus for emergency use authorization.
It’s tough to see how any company would be able to survive the year Theranos has had, but it will certainly be interesting to see what the response from CMS will be to this appeal.
