FDA grants breakthrough device designation to multiplex immunoassay in bladder cancer

The FDA has granted a breakthrough device designation to Oncuria, a novel noninvasive multiplex immunoassay used to predict response to treatment in patients with bladder cancer.1

Nonagen Bioscience Corp, the developer of Oncuria, explained in a press release that the device works by measuring 10 protein biomarkers in one voided urine sample. “Biomarker levels are [then] combined in a weighted algorithm to aid in the prediction of response to Bacillus Calmette-Guerin (BCG) in patients with intermediate-to–high-risk, early-stage bladder cancer,” the company added.

The breakthrough device designation will expedite the development and regulatory review of this immunoassay in bladder cancer. Benefits of the designation include priority review from the FDA for clinical trial protocols and commercialization decisions, and potentially facilitating Medicare reimbursement if the FDA approves the device.

"Our algorithm is designed to provide prediction of response to BCG therapy, allowing for timely interventions that could result in more favorable outcomes for our patients," Charles J. Rosser, CEO of Nonagen, stated in a press release. "We are proud that the FDA has decided to grant breakthrough device designation to our lead diagnostic, Oncuria, acknowledging growing recognition of the benefit our test can offer to clinicians and patients."

Although BCG is a standard approach recommended by treatment guidelines for patients with early-stage bladder cancer, over half of patients receiving BCG do not respond, according to the Nonagen release. Further, 1 in 5 patients experience disease growth and progression during or following BCG.

“A diagnostic test performed prior to BCG treatment capable of predicting treatment response could be leveraged to avoid a futile treatment regimen and avoid potential delays in the initiation of more appropriate clinical management, which will benefit both patients and the healthcare system,” the company noted.


1. Nonagen Bioscience Granted FDA Breakthrough Device Designation. Published online September 29, 2021. Accessed September 29, 2021. https://bit.ly/3F2zU8s.