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FDA Offers Human Plasma Panel to Developers of Zika Antibody Diagnostics

03:59 EDT 18 Aug 2017 | Genetic Engineering News

FDA is making a panel of human plasma samples available to help developers of serological Zika virus diagnostics verify that their assays can distinguish Zika virus infection from infection with West Nile or dengue viruses. The panel comprises plasma samples from anonymous individuals infected with Zika, West Nile and dengue viruses, and is available to diagnostic developers who have interacted with FDA through the pre-Emergency Use Authorization (pre-EAU) process, and have serological tests that are at the final validation stage. Other developers interested in requesting a panel may also contact the agency. "At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities," commented FDA Commissioner Scott Gottlieb, M.D. "By providing manufacturers of these tests ...

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