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FDA to Review Roche RT-PCR Dx for HIV, Hepatitis in Donated Blood and Plasma

NEW YORK (GenomeWeb News) — The US Food and Drug Administration will review a Roche Diagnostics test designed to diagnose HIV and hepatitis infections in donated blood and plasma, Roche said Wednesday.
 
The cobas TaqScreen MPX test is a real-time PCR-based single-multiplex assay that if approved would be used to detect HIV types 1 and 2 and hepatitis viruses C and B.
 
The tests would function on Roche’s cobas s 201 platform.

The Scan

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