FDA Approves Roche’s Donated Blood Screener

September 24, 2019

The FDA granted approval to Roche’s individual blood donation screening test for use on its cobas 6800/8800 systems.

Roche’s cobas Babesia test is a whole blood test used to screen donations. The company said it follows agency guidance that advises screening and testing for Babesia to reduce the parasite’s transmission from infusions.

The diagnostic test detects parasites that live in red blood cells. This is significant because the parasite can’t be detected in traditional plasma or serum samples, Roche said.

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