|
 The test, manufactured by a New Jersey-based unit of Swiss drugmaker
Roche Holding AG, may be used for screening donated blood in areas
with active mosquito-borne transmission of Zika virus, the FDA said.
(http://1.usa.gov/1RyqW1Z)
The regulator recommended last month that blood should no longer be
collected from regions in the United States where the Zika virus is
circulating.
At the time, the FDA also urged that areas with active Zika
transmission fulfill blood orders from areas where the virus is not
circulating, except when the blood is tested with an FDA-licensed or
investigational screening test.
"In the future, should Zika virus transmission occur in other areas,
blood collection establishments will be able to continue to collect
blood and use the investigational screening test, minimizing
disruption to the blood supply," said Peter Marks, director of the
FDA's Center for Biologics Evaluation and Research.
In early March, the U.S. Department of Health and Human Services
said it was arranging and funding shipments of blood products to
Puerto Rico to ensure an adequate supply of safe blood as the U.S.
territory struggles with Zika.
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On Wednesday, the FDA said that once screening using the
investigational test begins, blood establishments in Puerto Rico may
resume collecting donations.
Mounting evidence supports a link between Zika and microcephaly, a
birth defect that is a sign of incomplete brain development and
possibly other problems, such as miscarriage.
(Reporting by Natalie Grover in Bengaluru; Editing by Don Sebastian
and Shounak Dasgupta)
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