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FDA Clears Roche CMV Test for Marketing

NEW YORK (GenomeWeb News) – Roche today announced that the US Food and Drug Administration has given premarket approval for the firm's molecular test to assess a patient's viral load of cytomegalovirus.

The fully automated Cobas AmpliPrep/Cobas TaqMan CMV Test is the first FDA-approved laboratory test for quantifying CMV DNA in human plasma specimens, Roche said. The PCR-based test is designed to run on the Cobas AmpliPrep/Cobas TaqMan System and can be combined with the Cobas p 630 instrument, which provides an integrated pre-analytical primary tube handling solution.

Physicians can use the test to help manage patients diagnosed with CMV disease, particularly those whose immune systems have been suppressed for solid organ transplantation.

"With this test, laboratories now have an FDA-approved option for standardized and automated CMV viral load testing that improves the laboratory's workflow," Paul Brown, head of Roche Molecular Diagnostics, said in a statement.

The company plans to start shipping the test in the US in August.