Roche receives FDA authorization for Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems

August 06, 2020 – Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the U.S., the company claims. The authorization gives healthcare professionals the ability to run a large number of patient tests for the Epstein-Barr virus in a short period of time.

The cobas EBV test is a polymerase chain reaction (PCR) viral load test that runs on the fully automated and widely available cobas 6800 and cobas 8800 Systems. The test has been calibrated to the World Health Organization (WHO) International Standard. This means that test results are reported in international measures, making it possible for laboratories anywhere in the U.S. to obtain comparable results when measuring levels of EBV DNA.

The test was previously granted FDA Breakthrough Device designation.

The cobas EBV test has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL to 1E+08 IU/mL in EDTA plasma.

The test offers an alternative to lab-developed tests (LDTs) or Assay Specific Reagents (ASR) combinations, potentially minimizing variability and complexity in testing, reducing workload and alleviating risk for laboratories.

The fully automated cobas EBV test can be run on the cobas 6800/8800 Systems providing absolute automation with proven performance and flexibility. Simultaneous testing with CMV or other virology tests leads to time savings and increased efficiency, Roche says.

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