Theranos Gets Additional Week to Respond to U.S. Inspection

  • Blood-test startup has hired new director for California lab
  • Regulators had ordered changes at lab, threatened sanctions

Blood-testing startup Theranos Inc. said it has been given a one-week extension by U.S. regulators to say how it will fix flaws at a California laboratory.

Deficiencies at Theranos’s lab in Newark, California, “pose immediate jeopardy to patient health and safety,” officials at the U.S. Centers for Medicare and Medicaid Services said in a Jan. 25 letter. At the time, the agency demanded immediate changes at the lab and threatened the closely held company with sanctions. Theranos, which was given 10 days to respond, has hired a new lab director, Kingshuk Das. 

“CMS has granted an extension to February 12 for submission of our plan of correction, to allow our new Lab Director, Dr. Das, additional time to review our comprehensive response,” spokeswoman Brooke Buchanan said Friday in an e-mail.

CMS confirmed the extension in a statement, saying it was “a routine procedure in oversight of clinical labs.”

The CMS inspection was the latest incident to cast doubt on the Palo Alto, California-based medical-testing company, which also has drawn scrutiny from the U.S. Food and Drug Administration. Founded by billionaire entrepreneur Elizabeth Holmes, the startup has been under fire as critics have questioned the accuracy of its technology.

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