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September 5, 2016: The FDA Has Issued Emergency Authorization for Roche's Zika Test

“The U.S. Food and Drug Administration on Monday issued emergency authorization for a Zika diagnostics test from Swiss drugmaker Roche, skirting normal approval channels as the regulator moves to fight the disease’s spread.

“Zika virus, detected in Brazil and elsewhere last year before spreading to the Americas, is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.

“Through last week, the United States reported 2,517 Zika cases, 29 of which were likely acquired locally in Florida through mosquito bites and the rest brought in by travellers, the U.S. Centers for Disease Control and Prevention (CDC) said.

“Some 9,000 additional cases have been reported in U.S. territories, including Puerto Rico.

“With FDA approval, Roche’s test now can be used to screen patients exhibiting Zika symptoms that meet CDC criteria, including fever, rash, joint pain and red eyes. Samples will be sent for analysis to specially-certified U.S. laboratories with the appropriate equipment, a Roche spokesman said.

“’The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus,’ said Uwe Oberlaender, the head of molecular diagnostics at Basel-based Roche.

“The FDA issues such Emergency Use Authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.”

Source: Fortune

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