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FDA approves DNA test to determine CMV viral load
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The FDA has approved a DNA test that will help determine the progress of treatment in solid organ transplant patients who are being treated with cytomegalovirus antiviral therapy, according to an FDA press release.
The COBAS AmpliPrep/COBAS TaqMan cytomegalovirus (CMV) test (Roche) measures the viral load of CMV nucleic acid present in a patient’s blood plasma. Decreases in viral load between tests typically indicate that a therapy is working, whereas increases in viral load may prompt the need for different therapy, according to the release.
CMV causes severe diseases like pneumonia and colitis in people with weakened immune systems, which includes solid organ transplant patients. According to the press release, the US Health Resources and Services Administration’s Organ Procurement and Transplantation Network reported 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,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health, said in a press release.
Approval was based on clinical data from a randomized study of frozen plasma samples from 211 kidney transplant patients with CMV. They underwent 7 weeks of anti-CMV therapy. The study showed that a lower baseline viral load can predict a shorter time to CMV resolution.