UPDATE 1-U.S. FDA issues emergency use authorization for Zika test - Roche

lunes 29 de agosto de 2016 06:02 GYT
 

* Emergency FDA approval allows quick deployment during crisis

* Locally transmitted cases in Florida are mounting

* Testing allowed on those with Zika symptoms (Adds details about emergency approval)

ZURICH, Aug 29 (Reuters) - 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.   Continuación...