Roche Approved for First CMV Viral Load Test
Roche announced that it has received approval from the FDA for COBAS AmpliPrep/COBAS TaqMan CMV Test, a new test to assess a patient's viral load of cytomegalovirus (CMV).
The CMV DNA viral load information is used to help manage patients who have been diagnosed with CMV disease, specifically those whose immune system has been suppressed for solid organ transplantation. The test can be used to assess virological response to antiviral treatment. Roche's new 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.
Roche expects to begin shipping the new CMV test kit in August 2012.
For more information call (800) 526-6367 or visit www.roche.com.