First widely available Zika test OK'd for emergency use
The first commercial test for the Zika virus has been cleared for emergency use in the U.S. and could be available by next week.
The Food and Drug Administration granted the authorization Thursday to the test's developer, Quest Diagnostics, which said it would make it widely available to doctors for patient testing.
The company said the test results will initially be processed at a laboratory in San Juan Capistrano, California, which developed and validated the technology.
Eventually the test could be expanded to several dozen other Quest laboratories throughout the U.S. and in Puerto Rico. Previously Zika tests were only available through a handful of government-designated laboratories.
The new test detects genetic material known as RNA from the Zika virus in human blood serum.
Zika has become epidemic in Latin America and the Caribbean since last fall. The virus is mainly spread through mosquito bites and causes mild illness or no symptoms in most people. But it can cause microcephaly, a severe birth defect in which babies are born with abnormally small heads.
There have been 426 cases of Zika reported in the U.S. — all linked to travel to outbreak areas. But officials think it's likely some small clusters of Zika infections will occur in the U.S. when mosquito numbers boom.
The virus is spreading quickly across Puerto Rico and officials there recorded the first Zika-related U.S. death on Friday. Zika-related deaths in adults are considered extremely rare.
The U.S. territory is battling more than 700 Zika cases and seeks federal funds to help prevent an epidemic at a time of worsening economic crisis.