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Medical Devices / Submissions and Approvals

FDA Allows Marketing of InBios Diagnostic Test for Zika

May 29, 2019
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The FDA granted marketing clearance for InBios International’s diagnostic test to detect Zika virus antibodies in human blood, making it the first Zika diagnostic test the agency has allowed for marketing outside of emergency uses. The test was authorized in 2016 for emergency use under the FDA’s Emergency Use Authorization authority.

The approval was based on positive results from a clinical study of 807 test samples and a variety of analytical studies, which showed that the test was safe and effective at identifying IgM antibodies against Zika virus in blood.

“We ensured there were tests made available quickly under EUA, but we continued to work with diagnostic manufacturers to take the next step of ensuring products were FDA reviewed for safety and effectiveness and authorized under our traditional premarket authorities,” said FDA Acting Commissioner Ned Sharpless.

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