Roche receives FDA approval for cytomegalovirus viral load test

Friday, July 6, 2012 03:20 PM

Switzerland-based Roche has received premarket approval from the FDA for a new test to assess a patient's viral load of cytomegalovirus (CMV).

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.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs