As part of Johnson & Johnson’s commitment to combat Ebola, Janssen Pharmaceutica NV announced that the Idylla™ Ebola Virus Triage Test (Idylla™ EBOV Test) was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The Idylla™ Ebola Virus Triage Test is a diagnostic that detects the presence of the Ebola Zaire virus in patients with signs and symptoms of Ebola virus disease and was jointly developed by Janssen Diagnostics, a division of Janssen Pharmaceutica, Biocartis NV (Biocartis), and the Belgium Institute of Tropical Medicine.
The Idylla™ Ebola Virus Triage Test is a real-time reverse transcription polymerase chain reaction (rRT–PCR) test intended for the qualitative detection of RNA from the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in EDTA venous whole blood from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The blood sample is placed into a sealed cartridge and requires no further manipulation of potentially infected blood. After processing, the outside of the cartridge can be decontaminated prior to disposal. Results are delivered within 100 minutes. The Idylla™ Ebola Virus Triage Test does not require cold chain reagent storage. It is highly standardized, automated, and requires minimal training to interpret the results.
“We are very pleased that the FDA has granted Emergency Use Authorization for the Idylla™ Ebola Virus Triage Test,” commented Jorge Villacian, M.D., Chief Medical Officer, Janssen Diagnostics. “Across Johnson & Johnson, we are mobilizing our resources and expertise to help prevent another outbreak of Ebola.”
