FDA Issues Emergency Use Authorization for Ebola Test

November 16, 2018

The FDA granted an emergency use authorization (EUA) for a single-use, rapid fingerstick test for the Ebola virus, only the second test of its kind made available under an EUA.

The EUA authorization — which has been declared in the midst of the deadly pathogen’s outbreak in the Democratic Republic of the Congo — allows unapproved medical products to be used in emergency situations when there are no approved alternatives available.

Chembio’s Dual Path Platform Ebola Antigen System detects the virus in blood samples from patients that exhibit symptoms of the disease and other risk factors, such as excessive exposure to areas with large numbers of Ebola cases. Chembio’s device includes a portable reader and can be used in locations where healthcare providers don’t have access to PCR testing.

“It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats,” said FDA Commissioner Scott Gottlieb. “By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes.”

With this EUA authorization, the agency has now issued a total of 11 authorizations to help with the Ebola crisis, including nine nucleic acid tests. — James Miessler