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FDA Approves Viral Load Test for Organ Transplant Patients

Cytomegalovirus (National Institute of Standards and Technology)

Cytomegalovirus (National Institute of Standards and Technology)

The U.S. Food and Drug Administration today approved the first DNA test to gauge anti-viral treatments with solid organ transplant patients in  cytomegalovirus (CMV) antiviral therapy. The COBAS AmpliPrep/COBAS TaqMan CMV Test was is marketed by Roche Molecular Systems in Pleasanton, California.

CMV is a common virus that can cause severe diseases such as pneumonia or colitis, and is spread through direct contact with body fluids, such as urine, saliva, or breast milk. The virus is also spread through transplanted organs and blood transfusions, particularly in people with weakened immune systems. FDA cites statistics from the U.S. Health Resources and Services Administration indicating there were 28,538 solid organ transplants in the United States in 2011.

The Roche COBAS test quantifies the DNA of CMV in human plasma specimens. The test that Roche says is fully automated provides for clinicians data to indicate changes in a patient’s CMV viral load. Decreases in viral load from one test to the next may indicate that a therapy is effective, while an increase or no change may show the need for a different therapy. When used along with other clinical and laboratory data, this information can help clinicians manage and optimize patient care.

FDA based the pre-market approval on findings from a randomized, three-site clinical study of frozen plasma samples from 211 kidney transplant patients with confirmed CMV diagnosis, who underwent a seven-week course of anti-CMV therapy. The results of the study 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 a resolution of CMV disease.

The agency says the test is not approved as a screening test for the presence of CMV DNA in blood or blood products, nor is the test approved as a diagnostic test to diagnose CMV infection. The Roche test has also not been evaluated in newborns, pediatric patients, AIDS, or other immuno-compromised patients.

Roche expects to begin shipping the new CMV test kit in the U.S. in August 2012.

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