(HealthDay News) – The first DNA test to help doctors gauge the progress of antiviral treatment in solid organ transplant patients with cytomegalovirus (CMV) has been approved by the US Food and Drug Administration.
The COBAS AmpliPrep/COBAS TaqMan CMV Test is a viral load test intended to assess the amount of CMV nucleic acid present in a sample of a patient’s blood plasma. A clinician can use the test to look for changes in a patient’s CMV viral load in patients undergoing anti-CMV therapy. It is not approved for use as a screening or diagnostic test for CMV infection.
The 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, NJ.
The U.S. Department of Health and Human Services has more about solid organ transplant.