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www.fdanews.com/articles/178218-theranos-withdraws-fda-emergency-clearance-request-for-zika-test

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

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