CDC reports 10,772 confirmed Ebola cases and 5234 deaths, making this the second-largest outbreak on record. Kenya and Nigeria have reported cases.
|Articles|August 29, 2016
FDA Issues Emergency Authorization for Roche Zika Test
Author(s)Jenina Pellegren
On Monday, the US Food and Drug Administration skirted normal approval channels and issued Emergency Authorization for a Zika diagnostic test from the Swiss drug maker Roche.
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The US Food and Drug Administration (FDA) is facing
Approximately 9,000 cases have been reported in US territories, including Puerto Rico, where as many as 270 cases of microcephaly, a birth defect caused by the virus, are expected. In Brazil, Zika has been linked to more than 1,800 cases of microcephaly.
With FDA approval, Roche may now use the
In addition to CE, Roche has also developed the cobas Zika test for use with the cobas 6800/8800 Systems. This test has been approved by the FDA to initiate collection and testing of blood samples. It is currently being utilized in blood centers in the United States.
As Zika cases in Florida continue to rise and travelers arrive infected, the FDA issued Emergency Use Authorization, considering this a public emergency. This unapproved medical product will be deployed for as long as it is needed.
Diagnosis of Zika is based on a person’s recent travel history, symptoms, and test results. The CDC recommends testing for people who have been exposed to Zika through sex and who have symptoms. Pregnant women with possible exposure should also be tested. There is no specific medicine or vaccine for Zika, if you think you have or had Zika, treat the
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