Test Approved to Help Treat Common Infection in Transplant Patients
THURSDAY, July 5 -- The first DNA test to help doctors treat a common viral infection in people who have had a solid organ transplant has been approved by the U.S. Food and Drug Administration.
The cytomegalovirus (CMV) is a common viral infection, especially in people who have had their immune systems deliberately suppressed after an organ transplant. Among those who have had transplants of organs such as the heart, lung, pancreas or kidney, the virus can lead to diseases such as pneumonia or colitis, the FDA said in a news release.
Doctors commonly suppress the immune system to help prevent rejection of the transplanted organ, and may have to prescribe an anti-CMV therapy. Depending on a patient's increase or decrease in viral load as determined by the new test, doctors can measure a therapy's effectiveness.
The COBAS AmpliPrep/COBAS TaqMan CMV Test was evaluated in clinical studies involving 211 kidney transplant patients who had a confirmed diagnosis of CMV infection. The test was not evaluated in newborns, children, people with AIDS or those whose immune systems were compromised by something else, the FDA said.
The new test is manufactured by Roche Molecular Systems, based in Somerville, N.J.
The U.S. Department of Health and Human Services has more about solid organ transplant.
Posted: July 2012