Cytomegalovirus Viral Load Test Available in U.S.
First FDA-approved lab test for quantifying CMV DNA in plasma (Sept. 17)
Roche Diagnostics Corporation, based in Indianapolis, Ind., announced on September 17 that a new test to assess a patient’s viral load of cytomegalovirus (CMV) is commercially available. Physicians can use information from the test to help them manage patients who have been diagnosed with CMV disease — specifically, patients with an immune system that has been suppressed for solid-organ transplantation.
The real-time polymerase chain reaction (PCR)-based CMV test provides standardization of CMV viral-load monitoring and is designed for use on Roche’s automated COBAS AmpliPrep/COBAS TaqMan System.
The test received premarket approval from the FDA in July 2012. It is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens.
CMV disease in transplant recipients may be similar to infectious mononucleosis, with fever, malaise, and mild laboratory abnormalities, or it can be more serious, with involvement of the lungs or gastrointestinal tract. In the U.S., 50% to 80% of the population is infected with CMV. Although healthy persons usually have few symptoms at the time of initial infection, after infection the virus remains in a latent state in the body for the rest of a person's life. The virus can then be transmitted and cause infection through organ donation, or latent virus in the transplant recipient can become reactivated and cause symptomatic disease.
CMV is the most common viral infection in solid-organ transplant recipients.
For more information, visit the Roche Web site.