DNA Test to Track CMV Infection Gets FDA Nod

July 09, 2012

(Reuters) Jun 05 - U.S. health regulators on Thursday approved a first-of-its-kind DNA test by Swiss drugmaker Roche Holding AG to help physicians track progress in treating organ transplant patients for cytomegalovirus (CMV) infection.

Roche's COBAS AmpliPrep/COBAS TaqMan CMV Test is designed for use in solid organ transplant patients undergoing CMV antiviral therapy.

There were 28,538 solid organ transplants in the United States in 2011, according to the U.S. Health Resources and Services Administration.

Clinicians can measure the effectiveness of their treatment by using Roche's device and perform tests to track changes in the viral load of patients on anti-CMV therapy, the U.S. Food and Drug Administration said in a statement.

The approval was based on clinical data that showed the test's accuracy in measuring viral load and its ability to accurately measure variations in the amount of CMV.

The test, manufactured by Roche Molecular Systems, may not be used to diagnose CMV infection, the regulator added.


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