Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It authorized marketing of a diagnostic test for the Zika virus—specifically, Seattle-based InBios’ ZIKV Detect 2.0 IgM Capture Elisa for detecting immunoglobulin (IgM) antibodies in human blood, an assay previously cleared for emergency use only. Here’s the lowdown on the approval and its significance. Since then, two more Zika antibody detection tests with EUA status have gotten the green light to go commercial. The Context: About Zika  The Zika virus is spread to humans primarily through the bite of an infected Aedes mosquito. Although many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to the public health. Links between Zika virus infection and neurological complications (i.e., Guillain-Barré Syndrome), as well as microcephaly (abnormal smallness of the head) and other poor outcomes associated with Zika virus infection during pregnancy, have increased the importance of having diagnostic tests available for Zika virus. In 2016, the Centers for Disease Control and Prevention (CDC) announced that limited […]