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# FDA Approves Roche’s Cobas Zika Test
- URL: https://www.fdaweb.com/fda-approves-roches-cobas-zika-test/
- Published: 2017-10-05T12:00:00.000Z
- Updated: 2026-09-14T22:54:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139802

FDA has approved a Roche Molecular Systems PMA for the cobas Zika test, a qualitative nucleic acid test for detectimg Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. “The test’s clinical specificity was evaluated by testing individual samples from blood donations at five external laboratory sites, resulting in clinical specificity of more than 99%,” an FDA [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579313.htm?ref=fdaweb.com) says. It is intended for use on the company’s automated cobas 6800 and cobas 8800 systems.