Roche Gets FDA Nod for Emergency Use of Zika Virus Test

“At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion”, said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.

More than 2,500 people in the United States have been diagnosed with Zika, along with more than 9,000 in Puerto Rico and other US territories, according to the US Centers for Disease Control and Prevention.

On Monday, Swiss drugmaker Roche (ROG.S) said that the US Food and Drug Administration (FDA) has announced an Emergency Use Authorization (EUA) for the drugmaker’s test for the Zika virus.

The FDA issues such emergency-use authorisation during public health emergencies to quickly deploy unapproved medical products for as long as they are needed.

“I think there is scientific rationale for why that is important”, she said after a meeting of government officials in Miami Beach, the latest area hit by locally transmitted Zika cases. Expanded testing will continue to reduce the risk for transmission of Zika virus through the USA blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced. The agency had previously approved nine other systems for detecting Zika since February under similar emergency use authorizations.

In Brazil, the Zika virus has been connected with approximately 1,800 cases of microcephaly, Reuters added. The symptoms include fever, rash, joint pain and red eyes.

The mosquito-borne Zika virus has triggered an epidemic of birth defects that leave newborns with abnormally small heads and underdeveloped brains.

Luciana Borio, MD, the FDA’s acting chief scientist stated in a press release, “As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary…” In Brazil, the virus has been linked to more than 1,800 cases of microcephaly, and USA officials expect as many as 270 cases in Puerto Rico, where local transmission of the virus is widespread. For the rest of the USA, the FDA plans to enforce the guidelines within 12 weeks of the announcement.