FDA Grants Emergency Use Authorization for Zika Test

MAY 09, 2016
Krystle Vermes
Quest Diagnostics has received emergency use authorization from the FDA for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test).

The test is designed to detect RNA from the Zika virus in human serum specimens.

The Zika RT-PCR test is the first from a commercial laboratory provider to be granted emergency use authorization for testing patients for Zika virus RNA.  

Zika tests had only been available from the CDC and were only used in qualified laboratories designated by the CDC.

Quest Diagnostics said it would make the new test available to physicians this week.

"The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak," said Rick Pesano, vice president of research and development at Quest Diagnostics, in a press release. "Quest's expertise in molecular, infectious disease, and women's health diagnostics, and relationships with half of the country's physicians and hospitals, allow us to quickly make useful tests widely available for clinical use. This capability uniquely positions Quest to complement the response of public health laboratories for Zika outbreaks where access to FDA-authorized diagnostic tests can potentially influence the quality of patient management." 

The first US death associated with complications from Zika was reported in Puerto Rico, The New York Times reported. The CDC said the man, who was in his 70s, died in February 2016 from internal bleeding.

Recently, a laboratory in Mexico found the Zika virus in a species of mosquito called Aedes albopictus. This has been causing concern because these “Asian tiger” mosquitos have a broader range in the United States than the Aedes aegypti mosquito, which had been the species at the center of the Zika virus outbreak.