First Commercial Zika Virus Test Gets FDA Approval

Quest Diagnostics plans to make the new test available to doctors in May.

ByBRIAN MCBRIDE
April 29, 2016, 5:27 AM

— -- The Food and Drug Administration approved the first commercial U.S. test Thursday to diagnose the Zika virus.

The news comes as states and the federal government struggle to get ahead of the outbreak as it makes its way to the U.S.

Quest Diagnostics says it has received emergency authorization from the FDA to sell the first commercially developed diagnostic test for the mosquito-borne virus. Until now, doctors who wanted to test patients had to go through their state or local health departments.

Quest Diagnostics plans to make the new test broadly available to physicians for patient testing, including in Puerto Rico, early next week.

International and U.S. health officials have confirmed that the Zika infection during pregnancy can cause fetal microcephaly -- characterized by an abnormally small head and brain -- and other birth defects, and warned that local outbreaks in the United States are possible.

Symptoms of Zika include fever, rash, joint pain, and red eyes.

So far, there have been no confirmed cases of Zika spreading from mosquitoes to people in either Canada or the U.S. There have been a few cases reported of the virus transmitting through sexual contact in the U.S.

Three European countries -- France, Italy and Portugal -- are among the eight countries that have reported person-to-person transmission of the virus via sexual contact.

ABC News' Gillian Mohney contributed to this report

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