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 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

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.

The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

Already a subscriber?
Log in to your digital subscription.

Purchase the August issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs