Roche cytomegalovirus viral load test now available in the United States

Sept. 20, 2012

Roche has announced that a new test to assess a patient’s viral load of cytomegalovirus (CMV) is now commercially available. Physicians use information from the test to help them manage patients who have been diagnosed with CMV disease, specifically patients with an immune system that has been suppressed for solid organ transplantation. The test received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in July 2012.

The real-time polymerase chain reaction (PCR)-based CMV test provides standardization of CMV viral load monitoring with traceability to the World Health Organization (WHO) International CMV standard. It is designed for use on Roche’s fully automated COBAS AmpliPrep/COBAS TaqMan System, a 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. The COBAS AmpliPrep/COBAS TaqMan CMV Test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. The test can be used to assess virological response to antiviral treatment in this population.

Whitney Green, senior vice president, molecular diagnostics, Roche Diagnostics Corporation, says the test “will give diagnostic laboratories a standardized, FDA-approved option for CMV viral load testing that addresses a key medical need for transplant patients and provide physicians with clinically useful information to help them manage patients with CMV disease.” Learn more about the COBAS AmpliPrep/COBAS TaqMan System.