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FDA NEWS RELEASE

For Immediate Release: July 5, 2012
Media Inquiries: Michelle Bolek, 301-796-2973, michelle.bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves first DNA test to help manage CMV infection in organ transplant patients


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.  
 
“Tests such as the COBAS AmpliPrep/COBAS TaqMan CMV Test can play an important role in helping health care professionals appropriately treat patients,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health. 
 
The FDA’s approval of the COBAS AmpliPrep/COBAS TaqMan CMV Test was based on information that included an assessment of the test's accuracy in measuring viral load and its ability to accurately measure variations in the amount of CMV virus. 
 
The agency evaluated clinical data from a randomized, three-site study of frozen plasma samples from 211 kidney transplant patients with confirmed CMV diagnosis who underwent a seven-week course of anti-CMV therapy. Study results showed that a lower baseline viral load can predict a shorter time to resolution of CMV disease, and that significant declines in viral load are highly correlated to resolution of CMV disease.  
 
The test is not approved for use as a screening test for the presence of CMV DNA in blood or blood products or as a diagnostic test to diagnose CMV infection. It has not been evaluated in newborns, pediatric patients, AIDS, or other immunocompromised patients. Before switching to the COBAS AmpliPrep/COBAS TaqMan CMV Test, clinicians should compare and understand how the test method and results may differ from test methods and results currently used in their practice.
 
The COBAS AmpliPrep/COBAS TaqMan CMV Test is manufactured by the Roche Molecular Systems in Somerville, N.J.

For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
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