FDA Authorizes Emergency Use Test to Detect Zika
The FDA authorized emergency use (EUA) of Focus Diagnostics, Inc.’s Zika Virus RNA Qualitative Real-Time RT-PCR test to detect Zika virus in the blood of patients who have symptoms of Zika virus infection and live in, or have traveled to, an area with ongoing Zika virus transmission. This is the first commercial test to detect Zika virus authorized by FDA for emergency use.
An EUA is a tool that FDA can use to allow the use of certain medical products for emergencies based on scientific data. The U.S. Secretary of Health and Human Services (HHS) has declared that circumstances exist to allow the emergency use of authorized diagnostic tests for Zika virus infection, such as the Zika MAC-ELISA.