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July 6, 2012

FDA Sanctions Roche’s CMV Test

  • Roche’s Cobas® AmpliPrep/Cobas TaqMan® CMV test for evaluating cytomegalovirus (CMV) load received FDA premarket approval. The firm says the fully automated assay is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens. The assay is designed to aid in the management of solid organ transplant patients undergoing anti-CMV therapy by assessing virologic response to therapy.

    The real-time PCR-based test is designed for use on the Cobas AmpliPrep/Cobas TaqMan system, which can be combined with the cobas p 630 instrument to provide integrated preanalytical primary tube handling. “With this test, laboratories now have an FDA-approved option for standardized and automated CMV viral load testing that improves the laboratory workflow,” comments Paul Brown, Ph.D., head of Roche Molecular Diagnostics.

    Roche’s Cobas AmpliPrep/Cobas TaqMan system combines the Cobas AmpliPrep instrument for automated sample preparation with the Cobas TaqMan Analyzer or smaller Cobas TaqMan 48 Analyzer for automated RT-PCR. The system can be used for parallel processing of other molecular diagnostic assays for other infectious diseases. 

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