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

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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

­ Ref: Roche | Image: Roche 

Click here to­ read the full press release 

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