FDA Approves Commercial Zika Virus Test on Same Day First US Death Recorded

April 29, 2016 Updated: October 5, 2018

The first commercially available Zika virus test was approved by the Food and Drug Administration (FDA) on April 29 for emergency use, according to Quest Diagnostics, who developed the test.

Meanwhile, the Zika virus doesn’t seem to be diminishing.

“At this stage, based on the evidence available, WHO does not see an overall decline in the outbreak,” states the April 28 World Health Organization situation report.

The new test will become available starting next week in the United States, where 426 cases of Zika have been recorded as of April 27 by the Center for Disease Control and Prevention (CDC).

The test will also be available in Puerto Rico—where the first U.S.-related Zika death was reported on Friday. The CDC reported 596 Zika cases in United States territories, outside of the 50 states, mostly in Puerto Rico. 

The commercially available test means Zika tests do not have to be conducted exclusively by the CDC or a CDC-designated laboratory.

“For now, only the company’s Focus Diagnostics reference laboratory in San Juan Capistrano, Calif., which developed and validated the new test, will perform this test,” the company stated. 

Several dozen more laboratories designated by Focus Diagnostics, Inc. will soon be able to test for Zika infection, including one laboratory in Toa Baja, Puerto Rico.

Zika virus can cause microcephaly in newborns, if the mother was infected, causing the baby to be born with a smaller head and brain. It can also be deadly. In adults, Zika has been associated with the Guillain–Barré syndrome (GBS), a rapid-onset muscle weakness that can also cause death.

Among all the infected in the U.S. states and territories, 92 were pregnant. So far, there have been six cases of GBS related to Zika by the CDC.

Zika is spread by mosquitoes, but there hasn’t been a single case of a mosquito spreading the virus in the U.S.. In most cases people have been infected while abroad. The rest were infected sexually, since men can transmit the virus through intercourse, even weeks after losing any symptoms of the infection.

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