www.fdanews.com/articles/178218-theranos-withdraws-fda-emergency-clearance-request-for-zika-test
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Theranos Withdraws FDA Emergency Clearance Request for Zika Test
September 1, 2016
Theranos decided to rescind its request for FDA emergency clearance of its Zika nucleic acid-amplification-based assay.
The diagnostic tool, dubbed minilab, is intended to collect and process small blood samples on a compact testing platform.
The company studied the product in 16 studies across categories, including chemistry, immunochemistry, hematology and molecular biology. — José Vasquez