FDA OKs 1st widely available Zika test

Associated Press

WASHINGTON

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 initially will be processed at a laboratory in San Juan Capistrano, Calif., 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 available only 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 spread mainly 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 Friday. Zika-related deaths in adults are considered extremely rare.