Roche’s cobas Epstein-Barr Virus Test Receives the US FDA’s Authorization for Transplant Patients

August 5, 2020 Auto Bot Authorization, FDA, Latest, MedTech, receives, Roche, Test 0

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

Click here ­to­ read full press release/ article | Ref: Roche | Image: Fedaiisf