CMS says the company has 10 calendar days from date of receipt (January 25) to correct all the issues in question. If it doesn't, the lab may not be certified to perform tests under the CLIA program. Information about the letter leaked earlier this week.
The agency also highlighted issues with the analytic system and lab personnel performing high complexity testing.
That's bad news for the startup that's been criticized about its finger-prick testing technology. In October it was reported that the FDA only certified one out of the hundred or so tests the Theranos' technology was supposed to be able to get from a drop of blood. Plus, it was also reported that the company wasn't even using its proprietary technology to conduct most of those tests.
Concerning the letter from the CMS, Theranos sent Engadget an email with the following statement:
This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory's systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action. A full plan of correction will be submitted to CMS within days.
It also pointed out that the notice is only about its Newark, California facility and does not affect its lab in Arizona.