Order Oncuria^® - Nonagen Bioscience Clinical Laboratory

A next-generation oncology diagnostic

Nonagen's lead diagnostic, Oncuria^®, is a breakthrough multiplex immunoassay for the quantitative detection of biomarkers in urine that are associated with the presence of bladder cancer.

Bladder cancer is a highly recurrent type of cancer. In fact, up to 77% of early-stage bladder tumors treated with current approaches (tumor resection and/or intravesical bacillus Calmette-Guérin [BCG] or chemotherapy) will recur.¹ More than half of patients who receive BCG as the first-line treatment for bladder cancer will fail to respond, and in 20% of patients the disease grows and extends during or after BCG therapy.^2,3

A reliable urine test for improved bladder cancer management

Unlike current urine-based technologies, such as cytology, fluorescent probes, and mRNA, bladder cancer tumor proteins are well understood in the scientific literature and readily identified in the urine, enabling a more effective approach to cancer detection.

In clinical studies, Oncuria was shown to have 93% sensitivity and 93% specificity for detecting bladder cancer.⁴ Additionally, Oncuria has demonstrated consistent sensitivity and specificity across bladder cancer tumor grades and stages.⁴ Oncuria’s high level of accuracy is especially meaningful for detecting low-grade tumors, which is an area of high unmet need in bladder cancer management.

In September 2021, Oncuria received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for predicting the response to BCG therapy. That designation acknowledges the utility and potential clinical benefit of Oncuria and allows for expedited review with the FDA.

Who Can Order

Oncuria is available for ordering by qualified healthcare professionals and clinics evaluating patients for hematuria-related risk assessment and/or surveillance after a prior bladder cancer diagnosis.