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October 08, 2021

Nonagen’s Oncuria Nabs Breakthrough Status from FDA

Nonagen Bioscience Corp. has received FDA breakthrough device designation for its non-invasive bladder cancer test. The test, Oncuria, measures 10 protein biomarkers in urine samples and utilizes an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or whether they should proceed with other treatment options.

FDA grants Breakthrough Device Designation to technologies with potential to provide more effective diagnosis, treatment, or prognosis for life-threatening diseases such as cancer. The designation allows for close collaboration with, the FDA and expedited review.