30 August, 2016
"There is still much uncertainty regarding the nature and extent of Zika virus transmission", Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in the statement.
The FDA first issued guidance on February 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the USA without active virus transmission.
The key factor of the revised guidelines is that the FDA recommended risk reducing measures to fight Zika even outside the areas with active local transmissions.
Swiss drugmaker Roche (ROG.S) said on Monday the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization (EUA) for its test for the Zika virus. The FDA issues such Emergency Use Authorization during public health emergencies.
According to The Washington Post, Marks told reporters 11 states-Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina, and Texas-will begin testing blood donations for Zika virus within four weeks.More news: Trump immigration waffle reflects voter confusion on issue
In this context it is worth noticing that, despite the market availability of other diagnostic tests for identification of Zika virus like Quest Diagnostics, Inc.'s DGX Euroimmun Anti-Zika Virus Elisa and indirect immunofluorescence (IFA) test and a few others, FDA chose Hologic's Procelix to be one among the two for the nationwide screening. The Zika virus is transmitted primarily by the Aedes aegypti mosquito but can also be spread by sexual contact.
Zika virus, detected in Brazil and elsewhere previous year before spreading to the Americas, is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.
She was initially tested and admitted to hospital after suffering symptoms of joint pain and red eyes. "We are issuing revised guidance for immediate implementation in order to help maintain the safety of the USA blood supply".
The first local or non-travel related transmission of Zika virus in the U.S.by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands.
Uwe Oberlaender, Head of Roche Molecular Diagnostics, said, "The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus". There have been almost 2,500 cases of Zika in the USA linked to travel to outbreak areas and about 40 cases caused by mosquito bites in Florida. For the rest of the US, the FDA plans to enforce the guidelines within 12 weeks of the announcement.