FDAnews Device Daily Bulletin

Theranos Withdraws Zika Application

Sept. 8, 2016

Theranos has withdrawn its request for emergency use authorization for its Zika assay following an FDA inspection that found irregularities in protocols for the trials conducted in the Dominican Republic.  

The company had collected finger-stick samples from subjects, including individuals in the Dominican Republic, and submitted validation for its Zika assay to the FDA. — Tamra Sami

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