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# Roche PMA Approved for Cytomegalovirus Test
- URL: https://www.fdaweb.com/roche-pma-approved-for-cytomegalovirus-test/
- Published: 2016-05-25T12:00:00.000Z
- Updated: 2026-09-14T21:05:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135765

FDA has approved a Roche PMA for its cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients for monitoring CMV treatment. The company says the test was the first *in vitro* diagnostic test conforming to a WHO International Standard, making it possible for laboratories worldwide to obtain comparable results when testing for CMV. “Cytomegalovirus is the most important viral infection in hematopoietic stem cell transplant patients,” it says. The standardized real-time polymerase chain reaction-based CMV test is designed for use on the automated COBAS AmpliPrep/COBAS TaqMan System, Roche says. Its DNA measurements can be used to assess virological response to antiviral treatment, it says.