Roche Receives FDA Approval for Quantifying CMV DNA in Human Plasma Specimens

Roche has received premarket approval from the US Food and Drug Administration (FDA) for a new test to assess a patient’s viral load of cytomegalovirus (CMV). The fully automated COBAS® AmpliPrep/COBAS TaqMan® CMV Test is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens. Physicians use CMV DNA viral load information from the test to help manage patients who have been diagnosed with CMV disease, specifically patients whose immune system has been suppressed for solid organ transplantation.

Roche’s new real-time polymerase chain reaction (PCR)-based CMV test is designed for use on the fully automated COBAS AmpliPrep/COBAS TaqMan System, an established platform for viral load monitoring of multiple infectious diseases. The system can be combined with the cobas p 630 Instrument, which provides an integrated pre-analytical primary tube handling solution.

Roche expects to begin shipping the new CMV test kit in the US in August 2012.

Source: Roche