FDA clears Roche new viral load test

8 July 2012 (Last Updated July 8th, 2012 18:30)

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

Roche

The US Food and Drug Administration (FDA) has granted premarket approval 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, which is designed for use with the company's COBAS AmpliPrep / COBAS TaqMan system, is used as an aid in the management of solid organ transplant patients who are undergoing anti-CMV therapy.

The CMV DNA viral load information from the test can be used by physicians to manage CMV in patients whose immune system has been suppressed for solid organ transplantation.

The COBAS AmpliPrep / COBAS TaqMan system, which combines the COBAS AmpliPrep instrument for automated sample preparation and the COBAS TaqMan analyser real-time PCR for amplification and detection, can be used with the cobas p 630 instrument, which provides an integrated pre-analytical primary tube handling solution.

The AmpliPrep / COBAS TaqMan system also has parallel processing with other molecular diagnostics assays targeting hepatitis B virus, hepatitis C virus and human immunodeficiency virus diseases, according to the company.

Head of Roche Molecular Diagnostics, Paul Brown, said that with the test, laboratories have an FDA-approved option for standardised 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.


Image: Roche headquarters in Basel, Switzerland. Photo courtesy of: F. Hoffmann-La Roche Ltd.