August 18, 2016 | FDA Medical Countermeasures Initiative Update
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.
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.
- 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.
In case you missed it
- FDA Voice - FDA Working to Keep the U.S. Blood Supply Safe from Emerging Threats, by Peter Marks, MD, PhD and Luciana Borio, MD - en Español (August 5, 2016)