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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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