First diagnostic test for Zika virus gets FDA’s OK to market

From CBS News
May 29, 2019

Four years after Zika fever began making alarming waves on the global stage, the U.S. Food and Drug Administrating is allowing the marketing of the first test to detect the Zika virus in human blood.

The FDA’s authorization involves a test dubbed the ZIKV Detect 2.0 IgM Capture ELISA, made by InBios, a Seattle-based developer of diagnostic kits for viruses including West Nile and dengue. The company has “a niche in tropical, or neglected diseases,” said a spokesperson.

Zika was the first mosquito-born virus viewed as capable of causing severe birth defects on a large scale, with microcephaly — a condition in which infants are born with abnormally small heads and underdeveloped brains — one of its more horrid outcomes. There have also been increased reports of Guillain-Barre syndrome, an illness of the nervous system, in areas affected by Zika.

Read more