Roche’s cobas BKV Test Receives the US FDA’s 510 (k) Clearance to Improve Treatment for Transplant Patients

 Roche’s cobas BKV Test Receives the US FDA’s 510 (k) Clearance to Improve Treatment for Transplant Patients

Roche’s cobas BKV Test Receives the US FDA’s 510 (k) Clearance to Improve Treatment for Transplant Patients

Shots:

  • The test provides standardized results to assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options
  • It has received FDA’s BDD for improved treatment/diagnosis of life-threatening diseases for transplant patients. The approval allows Roche to offer HCPs a transplant testing portfolio that includes Cytomegalovirus, Epstein-Barr virus, and BK virus to monitor and improve care for transplant patients
  • The cobas BKV Test is a fully automated PCR viral load test that runs on cobas 6800/8800 Systems and has a robust coverage with a detection limit (21.5 IU/mL) and an expanded linear range (21.5 IU/mL to 1E+08 IU/mL) in EDTA plasma

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

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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