EUA for Zika Test
Vela Diagnostics Gets Emergency U.S. Authorization for Zika Test
HEALTH NEWS | Mon Sep 26, 2016 [Original Post]
Vela Diagnostics said its test for the Zika virus had received “emergency use authorization” from the U.S. Food and Drug Administration.
The test, already approved in Europe, is validated for plasma, serum and urine samples, the Singapore-based company said on Monday.
The FDA issues such emergency use authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.
The regulator last month issued a similar authorization for a Zika diagnostics test from Swiss drugmaker Roche.
Zika, which was detected in Brazil, has spread to the Americas and is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.
In adults, it has been linked to Guillain-Barre syndrome, a temporary paralysis. The disease has since spread to parts of Southeast Asia.