Zika Diagnostic EUA

First commercial serological test available under EUA

On August 17, 2016, FDA issued (PDF, 528 KB) an Emergency Use Authorization (EUA) for emergency use of InBios International, Inc.’s ZIKV Detect™ IgM Capture ELISA for the presumptive detection of Zika virus IgM antibodies in human sera. This is the first commercially available serological test for Zika available under EUA (the first serological test, the CDC Zika MAC-ELISA, was initially authorized for use in February 2016).

An EUA is a tool FDA can use to allow the use of certain medical products for emergencies based on scientific data. Including the ZIKV Detect™ IgM Capture ELISA, FDA has issued 9EUAs for Zika diagnostic tests, as of August 18, 2016.

View all Zika diagnostic EUAs, including fact sheets and instructions for use

Related information

Cross-Species Immune System Reference

In an MCMi Regulatory Science project, Stanford University researchers used mass cytometry to conduct the first single-cell comprehensive cross-species analyses of immune system function. The resulting data, including analysis tools to evaluate results, are now available to the research community through a free, open-accesswebsite.

Events

September 12-13, 2016: Public Hearing - Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (Bethesda, MD and webcast)

September 12-13, 2016: Public Workshop - Pediatric Clinical Investigator Training(Bethesda, MD and webcast) - Register by September 6, 2016

September 13-14, 2016: Public Workshop - Sequencing Quality Control II(Bethesda, MD)

September 23, 2016: Pediatric Master Protocols public workshop (Silver Spring, MD and webcast) - Advance registration required. Fee to attend in-person.