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Theranos Can't Stop Getting in Trouble With FDA

This time for its Zika test
By Michael Harthorne,  Newser Staff
Posted Aug 31, 2016 4:26 PM CDT

(Newser) – And the hits keep on coming for medical technology company Theranos. In an attempt to move on following a federal criminal investigation into its laboratories, Theranos announced it was submitting a Zika blood test for emergency-use authorization at the start of August, the Washington Post reports. Theranos claimed it successfully trialed the miniLab Zika test on blood samples from the Dominican Republic. But according to the Wall Street Journal, FDA regulators discovered that some of those trials were done without "implementing a patient-safety protocol approved by an institutional review board." Now Theranos has withdrawn its clearance request for the Zika test.

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"Given the amount of scrutiny they're under, I would have expected them to be particularly careful about the regulatory issues surrounding research on human subjects," one expert tells the Post. Theranos is already facing sanctions, and founder Elizabeth Holmes (soon to be played onscreen by Jennifer Lawrence) was banned from owning or operating a laboratory for two years. The miniLab, which is meant to be used outside a laboratory, was an attempt to get around that ban, Engadget reports. Theranos plans on appealing the FDA's ruling while also redoing the trials and resubmitting for clearance. "In my mind, this was a positive interaction with the FDA," the Post quotes one Theranos executive as saying. (Read more Theranos stories.)

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