Nonagen Bioscience

Nonagen Bioscience, founded in 2011 and operating from a clinical laboratory in Irvine, California, developed Oncuria, a urine-based multiplex protein immunoassay combined with clinical data and proprietary algorithms for bladder (urothelial) cancer. Three tests are offered: Oncuria-Detect for detection in patients with haematuria, Oncuria-Monitor for recurrence surveillance, and Oncuria-Predict for predicting response to intravesical BCG in non-muscle invasive bladder cancer. Oncuria-Predict received FDA Breakthrough Device Designation in September 2021; the platform gained CE marking in 2022, CPT codes (0365U to 0367U) in 2023, Medicare payment rates from January 2024 and CAP accreditation of the Irvine laboratory in 2026. The company reports more than 5,500 patients tested, over 40 publications and more than $21 million in NIH and NCI funding.