Theranos has withdrawn its application to the Food and Drug Administration for an emergency clearance of a new diagnostic blood test for Zika virus infections, according to the Wall Street Journal. The FDA’s emergency clearance process, used in times of extraordinary medical need, such as the current Zika outbreaks, is a lower regulatory hurdle than normal for new medical products.
The Zika test would have been carried out on Theranos’ new MiniLab device; both were unveiled August 1 at a conference of the American Association for Clinical Chemistry. However, during a subsequent lab inspection, the FDA found that the company had collected some of the data on its Zika test prior to having patient-safety protocols in place. Theranos informed investors that it “recognized” the problem during the inspection and decided to withdraw its application.
The move is yet another stumble for the company, which appears to be trying to rebrand itself as a device manufacturer after federal regulators handed down heavy sanctions for safety issues in its clinical diagnostic work.
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Source: Ars Technica – Theranos reboot stalls as new test fails FDA standards—which were low