(By Balaseshan) Roche Holding Ltd. (PINK:RHHBY) said it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for a new cytomegalovirus (CMV) viral load test.
Roche expects to begin shipping the new CMV test kit in the U.S. in August 2012. CMV is the most common and important viral infection in solid organ transplant (SOT) recipients.
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.
Roche said 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.
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.
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. In this population, the test can be used to assess virological response to antiviral treatment.
The test is traceable to the first WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques and reliably monitors cytomegalovirus (CMV) infections.
The CMV 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.
CMV disease in transplant recipients may be similar to infectious mononucleosis with fever, malaise and mild laboratory abnormalities, or can be more serious with involvement of the lung or gastrointestinal tract. Between 50% and 80% of all people in the U.S. become infected with CMV.
RHHBY is trading down 1.41% at $42.83 on Thursday. The stock has been trading between $36.50 and $46.40 for the past 52 weeks.