Logo

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

Share this
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

­ Ref: Roche | Image: Roche 

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions