FDA approves Roche new viral load test

WASHINGTON DC -- The U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) to Roche’s new fully automated COBAS AmpliPrep/COBAS TaqMan CMV test for the quantification cytomegalovirus’ (CMV) DNA in human plasma specimens.

The CMV test is real-time and polymerase chain reaction (PCR)-based, and is designed for use on the company’s COBAS AmpliPrep/COBAS TaqMan system. Information from the test can be used for the management of CMV patients, whose immune system has been suppressed for solid organ transplant.

The system can be combined with cobas p 630 Instrument, which provides an integrated preanalytical primary handling solution.