Shots:

• The US FDA has granted de novo class II for cobas EBV test- providing HCPs a tool for monitoring transplant patients at risk for complications from infections or reactivations of EBV
• The cobas EBV test is a PCR viral load test that runs on the fully automated and widely available cobas 6800/8800 systems and has been calibrated to WHO’s international standard
• The test has received the FDA’s BDD and has robust coverage with a limit of detection of 18.8 IU/mL and an expanded linear range from 35 IU/mL-1E+08 IU/mL in EDTA plasma

­ Ref: Roche | Image: Roche