The U.S. Food and Drug Administration today approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
The COBAS AmpliPrep/COBAS TaqMan CMV Test is a viral load test that can help determine the amount of CMV nucleic acid present in a sample of a patient's blood plasma. While a patient is undergoing anti-CMV therapy, a clinician can use the device to perform a series of tests to look for changes in a patient's CMV viral load. A significant decrease in viral load from one test to the next may indicate that a particular therapy is effective, while an increase or no change may indicate the need for a different therapy. When used along with other clinical and laboratory data, this information can aid clinicians to manage and optimize patient care. CMV is a common virus that can cause severe diseases such as pneumonia or colitis in people with weakened immune systems, including solid organ transplant patients. Solid organ transplants include heart, lung, pancreas, kidney, or small intestine transplants. Transplants of tissue or cells, such as bone marrow, skin, or muscle, are not included. The U.S. Health Resources and Services Administration's Organ Procurement and Transplantation Network reports that there were 28,538 solid organ transplants in the United States in 2011.