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Roche new viral load test wins FDA nod

The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Roche's new fully automated COBAS AmpliPrep / COBAS TaqMan CMV test to quantify cytomegalovirus' (CMV) DNA in human plasma specimens.

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

The COBAS AmpliPrep/COBAS TaqMan system combines the COBAS AmpliPrep instrument for automated sample preparation and the COBAS TaqMan Analyzer real-time PCR for amplification and detection.

The AmpliPrep/COBAS TaqMan system can also be used with the cobas p 630 instrument which provides an integrated pre-analytical primary tube handling solution.

Roche Molecular Diagnostics head Paul Brown said with the test, laboratories now have an FDA-approved option for standardized and automated CMV viral load testing that improves the laboratory’s workflow.

"It provides physicians with clinically useful information to aid in the management of solid organ transplant patients with CMV disease," Brown added.