FDA Grants J&J Ebola Test “Emergency Use Authorization”

NEW BRUNSWICK, NJ–Johnson & Johnson (J&J) said on June 1 the Ebola virus triage diagnostic test it developed with the Institute of Tropical Medicine in Belgium is now authorized by the U.S. Food and Drug Administration for emergency use.

The test detects the presence of the Ebola Zaire virus when patients exhibit signs and symptoms of the disease.

Co-developed by J&J’s pharmaceutical subsidiary Janssen, their Beglian partner Biocartis NV, and the Institute, the “test will help prevent future outbreaks of Ebola,” says J&J.

"The 2014 Ebola virus outbreak in West Africa was the largest outbreak [ever]. With over 11,000 deaths reported… that outbreak demonstrated a clear need for improved infectious disease surveillance and management," reads the J&J News release.

"Today, further preparation is needed, as specialists expect sporadic Ebola virus outbreaks to continue in the future.”

“Across Johnson & Johnson, we are mobilizing our resources and expertise to help prevent another outbreak of Ebola,” said Janssen’s chief medical officer Jorge Villacian, adding that J&J is very pleased the “Idylla” Ebola test is authorized for emergency use.

The new test can reportedly distinquish Ebola from other fevers like malaria in just over an hour-and-a-half. 

It is highly standardized, automated, and requires very little training to read and interpret the results, according to J&J.

Business Reporter at New Brunswick Today | dschatz@nb.today

Dave is an award-winning business reporter who has authored over 200 articles for New Brunswick Today.