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# FDA OKs Roche Test for Transplant Patient Monitoring
- URL: https://www.fdaweb.com/fda-oks-roche-test-for-transplant-patient-monitoring/
- Published: 2017-06-05T12:00:00.000Z
- Updated: 2026-09-14T22:27:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138851

FDA has approved a Roche PMA supplement for the cobas CMV (cytomegalovirus) test for use on its automated cobas 6800 and cobas 8800 Systems. The test provides healthcare providers with information to assess how transplant patients on therapy are responding to treatment. “The test is standardized to the 1st WHO International Standard for improving harmonization in CMV testing results across hospital institutions,” the company says.

  
cobas CMV is a real-time PCR (polymerase chain reaction) test designed to offer an expanded linear range from 34.5 IU/mL to 1E+07 IU/mL with coverage across genotypes, Roche says. “The test minimizes variability and complexity in testing offering an alternative to lab-developed tests (LDTs) reducing workload and alleviating risk for laboratories,” it adds.