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.