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Roche: FDA approves blood test for donor screening


Actualité publiée le 20/09/19 10:47

(CercleFinance.com) - Roche has received approval from the US Food and Drug Administration for a test for individual blood donation testing, the Swiss drugmaker said on Friday.

The move follows FDA guidance recommending screening and testing for Babesia, an infection that can be fatal in patients receiving blood transfusions from infected donors.

Roche's cobas system will now detect parasites that live in red blood cells, given that the Babesia parasite cannot be detected in traditional plasma or serum samples.

This is Roche's first commercially available full blood test to screen donations.

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