FDA Issues EUA for Roche Ebola MDx Test
Monday, December 29, 2014
Source: Genome Web
The US Food and Drug Administration has issued an Emergency Use Authorization for Roche's LightMix Ebola Zaire rRT-PCR Test, a molecular diagnostic test for use by CLIA high-complexity laboratories or similarly qualified non-US labs.
The test is a real-time RT-PCR assay for the qualitative detection of Ebola virus RNA in human EDTA whole blood specimens from individuals with signs and symptoms of infection in conjunction with epidemiological risk factors.