FDA Allows Emergency Use of Corgenix Rapid Ebola Test

Broomfield, Colo.-based Corgenix’s ReEBOV Antigen Rapid Test received FDA authorization for emergency use to detect the Ebola Zaire virus in individuals who display symptoms or were in areas with Ebola outbreaks, the company said Thursday.

ReEBOV is the first rapid diagnostic test and the first immunoassay to be authorized for this indication, Corgenix said. The test will be used in situations where time is of the essence. While molecular tests are more sensitive in detecting Ebola Zaire, they can take days to return results. By contrast, Corgenix’s rapid test can diagnose suspected cases in 15 to 25 minutes.

The test can be used in any clinical facility that is sufficiently equipped to perform it, the company said. It is not intended for use in general Ebola virus screening, such as airport screening or contact tracing.

The U.S. authorization comes on the heels of last week’s World Health Organization listing for procurement of the test, making it available worldwide. — Kellen Owings