FDA Approval for Roche’s Cytomegalovirus Viral Load Test
5 Jul 2012
Roche Molecular Diagnostics has announced that it has received premarket approval from the U.S. Food and Drug Administration (FDA) for a new test to assess a patient’s viral load of cytomegalovirus (CMV).
CMV is the most common and important viral infection in solid organ transplant recipients. The virus can be transmitted through the donor organ, resulting in CMV infection and leading to the development of CMV disease, or can occur by reactivation of the virus in transplant recipients with previous CMV infection.
The fully automated COBAS® AmpliPrep / COBAS® TaqMan® CMV Test is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens. 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.
“We are pleased to offer this innovative test to address a key medical need for immunosuppressed solid organ transplant patients,” said Paul Brown, Ph.D., head of Roche Molecular Diagnostics. “With this 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.”
Roche’s new real-time 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. The system can be combined with the cobas p 630 Instrument, which provides an integrated pre-analytical primary tube handling solution.
Roche expects to begin shipping the new CMV test kit in the U.S. in August 2012.