Home » Nonagen Bioscience’s Bladder Cancer Test Designated Breakthrough Device
Nonagen Bioscience’s Bladder Cancer Test Designated Breakthrough Device
The FDA has granted a Breakthrough Device designation for Nonagen Bioscience’s Oncuria noninvasive bladder cancer test.
The multiplex immunoassay measures 10 protein biomarkers in a single urine sample. It then combines biomarker levels in a weighted algorithm to help predict how well patients with intermediate- to high-risk, early-stage bladder cancer will respond to Bacillus Calmette-Guerin immunotherapy.
The test’s ability to predict how well bladder cancer patients will respond to therapy allows for “timely interventions that could result in more favorable outcomes,” the company said.
Upcoming Events
-
23Apr
-
25Apr
-
07May
-
14May
-
30May