On May 23, 2019, the U.S. Food and Drug Administration (FDA) announced that it had authorized InBios’ marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood.

The ZIKV Detect 2.0 IgM Capture ELISA was the first Zika diagnostic test the FDA had allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies – including the ZIKV Detect 2.0 IgM Capture ELISA – had been authorized only for emergency use under the FDA’s Emergency Use Authorization (EUA) authority.