FDA Clears Roche CMV Test for Marketing | GenomeWeb

NEW YORK (GenomeWeb News) – Roche today announced that the US Food and Drug Administration has given premarket approval for the firm's molecular test to assess a patient's viral load of cytomegalovirus.

The fully automated Cobas AmpliPrep/Cobas TaqMan CMV Test is the first FDA-approved laboratory test for quantifying CMV DNA in human plasma specimens, Roche said. The PCR-based test is designed to run on the Cobas AmpliPrep/Cobas TaqMan System and can be combined with the Cobas p 630 instrument, which provides an integrated pre-analytical primary tube handling solution.

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