The FDA has approved a DNA test – COBAS AmpliPrep/COBAS TaqMan CMV Test – to measure the efficacy of anti-viral treatment in solid organ transplant recipients who are being administered CMV (cytomegalovirus) antiviral therapy. The viral load test can determine, from a sample of the patient’s blood plasma, levels of CMV nucleic acid.
The doctor can use the device to carry out a series of tests to determine what changes there are in the paient’s CMV viral load while undergoing anti-CMV therapy.
A large drop in viral load between tests may mean that a specific therapy is effective, while no change or a rise in viral load may mean that the therapy is not working and a different one is needed.
If the fully automated COBAS AmpliPrep/COBAS TaqMan CMV Test is used in combination with other laboratory and clinical data, the doctor can better manage and optimize patient care.
CMV can cause severe illness in patients with compromised immune systems, including solid organ transplant recipients. Complications include pneumonia, colitis, and liver problems. Solid organ transplant refers to transplants of the small intestine, kidney, pancreas, lung, or heart. Recipients of tissue, or cells, such as skin, muscle or bone marrow do not have so high a risk.
In 2011, there were 28,538 solid organ transplant procedures in the USA, according to the U.S. Health Resources and Services Administration’s Organ Procurement and Transplantation Network.
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, said:
“Tests such as the COBAS AmpliPrep/COBAS TaqMan CMV Test can play an important role in helping health care professionals appropriately treat patients.”
The FDA approved the COBAS AmpliPrep/COBAS TaqMan CMV Test after reviewing data on the test’s accuracy in measuring viral load, as well as its ability to measure variations in CMV quantities accurately.
The FDA examined data from a randomized trial which took place in three sites – frozen plasma samples from 211 kidney transplant recipients with confirmed CMV diagnosis had undergone a 7-week course of anti-CMV therapy were used.
The trial demonstrated that a lower baseline viral load usually means a shorter time to resolving the CMV disease, while considerable falls in viral load are closely associated with resolution of CMV disease.
The COBAS AmpliPrep/COBAS TaqMan CMV Test is not a diagnostic tool for determining whether somebody has CMV infection, and neither is it approved as a screening test for CMV DNA presence in blood or blood products, the FDA stressed.
The COBAS AmpliPrep/COBAS TaqMan CMV Test is made by the Roche Molecular Systems in Somerville, N.J.
Paul Brown, Ph.D., head of Roche Molecular Diagnostics, said:
“We are pleased to offer this innovative test to address a key medical need for immunosuppressed solid organ transplant patients.
With this test, laboratories now have an FDA-approved option for standardized and automated CMV viral load testing that improves the laboratory’s workflow. It provides physicians with clinically useful information to aid in the management of solid organ transplant patients with CMV disease.”
Roche says that its new real-time polymerase chain reaction (PCR)-based CMV test is specifically made to be used on the fully automated COBAS® AmpliPrep/COBAS® TaqMan® System, what the company describes as “an established platform for viral load monitoring of multiple infectious diseases. The system can be combined with the cobas p 630 Instrument, which provides an integrated pre-analytical primary tube handling solution.”
In a communique issued today, Roche wrote:
“The COBAS® AmpliPrep / COBAS® TaqMan® CMV Test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. In this population, the test can be used to assess virological response to antiviral treatment. The test is traceable to the first WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162) and reliably monitors cytomegalovirus (CMV) infections.”
Deliveries of the new CMV test kit should commence next month, Roche expects.
As mentioned earlier, CMV is the most common viral infection in SOT (solid organ transplant) patients; it is also the most important because of the complications associated with it for some transplant recipients. The patient can become infected through the donor organ, which can develop into a CMV infection. Some transplant recipients may already have CMV in their system from a previous infection; the virus which had lain dormant reactivates.
According to Roche, between 50% and 80% of all US citizens become infected with CMV.
Most healthy people who have the virus inside their system have either none or very mild symptoms. After infection, the virus remains within the body for the rest of the person’s life, in a latent state.
Written by Christian Nordqvist