On September 28, 2021 Nonagen Bioscience Corp, pioneers in the development of liquid biopsy tests for the detection of human cancers, reported Oncuria, their non-invasive bladder cancer test capable of predicting response to therapy, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation (Press release, Nonagen Bioscience, SEP 28, 2021, View Source [SID1234590430]).

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This designation is granted to technologies that have the potential to provide more effective treatment, diagnosis or prognosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by the FDA, and provides formal acknowledgement of Oncuria’s utility and potential clinical benefit.

FDA Grants Nonagen Bioscience Test Breakthrough Device Designation

Up to 50% of early-stage bladder tumors treated with surgery will recur. Guidelines for the treatment of early-stage bladder cancer recommend the instillation of Bacillus Calmette-Guerin (BCG) into the bladder. BCG is an attenuated tuberculosis vaccine that acts as a non-specific immune system stimulant and as such is one of the first immunotherapies to treat human cancer. It has proven to be a successful treatment, assisting in the eradication of residual bladder cancer, reducing recurrence rates and decreasing the progression to more advanced cancers. However, more than half of patients who receive BCG fail to respond, and in 20% of patients the disease grows and extends during or after BCG, which portends a worse survival. 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.

Oncuria, a multiplex immunoassay measures 10 protein biomarkers in a single voided urine sample. Biomarker levels are combined in a weighted algorithm to aid in the prediction of responding to BCG in patients with intermediate to high-risk, early-stage bladder cancer. "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," said Charles J. Rosser, CEO of Nonagen. "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."