SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY.PK) announced that it has received premarket approval or PMA from the U.S. Food and Drug Administration or FDA for a new test to assess a patient's viral load of cytomegalovirus or CMV.
According to the company, the fully automated COBAS AmpliPrep / COBAS TaqManCMV Test is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens.
The company noted that the 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 said its new real-time polymerase chain reaction or 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 said it expects to begin shipping the new CMV test kit in the U.S. in August 2012.
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