FDA authorizes use of diagnostic test to detect Ebola
Aug 6 (Reuters) - The U.S. Food and Drug Administration on Wednesday said a diagnostic test developed by the Department of Defense to detect Ebola has been authorized for use in helping to contain the world's worst outbreak of the deadly virus.
The DoD EZ1 Real-time RT-PCR Assay, an in vitro diagnostic that has not yet been approved, was authorized for use in laboratories designated by the Department of Defense to help respond to the ongoing Ebola outbreak in West Africa, the FDA said.
It is intended for use by U.S. Defense personnel with signs and symptoms of Ebola or who are at risk for exposure to the virus, or who may have been exposed to it, the agency said. It may also be used to test aid workers and responders as needed.
More than 900 people have died in an ongoing Ebola outbreak in West Africa. The outbreak of the hemorrhagic fever has overwhelmed rudimentary healthcare systems and prompted the deployment of troops to quarantine the worst-hit areas in the remote border region of Guinea, Liberia and Sierra Leone.
The FDA can issue an "emergency use authorization" for an unapproved medical product or the unapproved use of an approved medical product during emergencies when there are no adequate, approved and available alternatives.
The agency may invoke the authorization in emergency situations or to prepare for an emergency situation.