Roche submits blood test for FDA review
The diagnostics unit of Swiss drug major Roche says that the US Food and Drug Administration has accepted for review its application for a new test designed to detect a broad range of HIV and viral hepatitis infections in donated blood and plasma.
The product, called the cobas TaqScreen MPX Test, uses real-time polymerase chain reaction to detect HIV type 1, HIV type 2, hepatitis C and B viruses in a single multiplex assay. The test is designed for use on Roche's newly-automated, modular cobas 201 platform.
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