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Ebola Test From J&J's Janssen Pharmaceutica Granted EUA by FDA

NEW YORK (GenomeWeb) – Johnson & Johnson affiliate Janssen Pharmaceutica announced today that its Ebola assay has been granted Emergency Use Authorization by the US Food and Drug Administration.

The Ebola Virus Triage Test, performed on the Biocartis Idylla platform, is a closed-tube real-time reverse transcription PCR test for qualitative detection of the virus in samples of whole blood. The automated test does not require cold chain storage, runs in 100 minutes, and requires minimal training to interpret results, Janssen noted in a statement. 

The EUA stipulates that testing is for individuals with signs and symptoms of Ebola combined with epidemiological risk factors. The 2014 outbreak in West Africa led to more than 11,000 deaths, with the US Centers for Disease Control and Prevention expecting additional cases to occur sporadically in the future.

The Ebola Virus Triage Test was jointly developed by Janssen's diagnostics division, Biocartis, and the Belgium Institute of Tropical Medicine. It has been in development since 2015, and is the twelfth Ebola assay to be granted EUA since the emergency was declared — nine of the 12 authorized tests are RT-PCR-based.

Janssen is also developing other tests in the infectious disease space for the fully automated, random-access Idylla platform, including ones for hepatitis C viral load and influenza surveillance. The firm's influenza A/B and RSV panel was CE-marked last year.

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