Theranos Given Extension To Correct Serious Lab Deficiencies

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Publish Date:
February 5, 2016
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KQED
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Summary

The blood testing startup Theranos got a little more time, Friday.

The Centers for Medicare & Medicaid Services sent this statement today:

“At the request of the laboratory’s director, Theranos was granted an extension until February 12 to submit their response to the CMS inspection report. This is a routine procedure in oversight of clinical labs.”

Hank Greely is the director of Stanford’s Center for Law and the Biosciences. He said in an email that “it wouldn’t shock” him if CMS’ assertion of potential fatal consequences wasn’t literal.

He said the language “is enough to at least raise serious questions about getting customers/patients to get new tests.”

Greely said the haste in which Theranos should be obligated to contact potentially affected patients would be determined by the substance and frequency of the errors CMS found.

Greely said he thought it would behoove Theranos to offer affected patients or even every patient a free retest, if it was able to do so.

“Good PR, good for the patients (if the retests are accurate), and, if their tests are as cheap as they say they are, not expensive.”

Greely said though the details of disclosure are complicated and depend on many factors, “the idea that you should not let your customers rely on test results you have reason to think had a good chance of being inaccurate is not [complicated].”

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