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Roche: FDA Authorizes Cobas Epstein-Barr Virus Test For Transplant Patients

Swiss drug maker Roche (RHHBY) announced Wednesday that the U.S. Food and Drug Administration has authorized the cobas Epstein-Barr virus or EBV test to improve care for transplant patients. This is the first quantitative in vitro diagnostic test for EBV DNA in the United States.

EBV is a member of the herpes virus family and has been associated with a range of cancers in transplant patients.

The cobas EBV test is a real-time polymerase chain reaction or PCR viral load test that runs on the fully automated and widely available cobas 6800 and cobas 8800 Systems.

The test potentially minimizes variability and complexity in testing, reducing workload and alleviating risk for laboratories.

The test has been calibrated to the World Health Organization International Standard for consistent result reporting among laboratories across the U.S., allowing for results to be easily comparable across hospitals and labs.

The test has already received FDA Breakthrough Device designation, which enables an expedited review process for medical devices that provide improved treatment or diagnosis of life-threatening diseases or conditions.

Thomas Schinecker, CEO Roche Diagnostics, said, "Monitoring of Epstein-Barr virus DNA can help prevent progression of life-threatening diseases, such as cancer in transplant patients. The EBV test helps set a new standard of care for patients, as healthcare professionals now can act early in the management of this virus with best-in-class monitoring tools and can make more informed decisions when treating patients."

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