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FDA Approves Roche's CMV Test

NEW YORK (GenomeWeb) – Roche today announced the US Food and Drug Administration has approved the company's Cobas cytomegalovirus test for use on the fully automated Cobas 6800 and 8800 systems.

The real-time PCR-based Cobas CMV test is for assessing how transplant patients on therapy respond to treatment. It offers an expanded linear rage from 34.5 IU/mL to 1E+07 IU/mL with robust coverage across genotypes, Roche said, adding that the test minimizes variability and complexity testing, reducing workload and risk for laboratories offering laboratory-developed tests.

The Cobas CMV test can be simultaneously run with HIV-1 and HCV assays on the Cobas 6800/8800 systems, Roche said. It also is standardized to the First World Health Organization International Standard for improving harmonization in CMV testing results across hospital institutions.

Uwe Oberlaender, head of Roche Diagnostics, said in a statement that with the second-generation test, "clinicians can now receive faster, more reliable, standardized results aligned across institutions. This is a required and important step toward optimizing CMV management decisions for transplant patients."