A closer look at Oncuria®

A novel diagnostic to detect, predict, and monitor bladder cancer

Thank you for your interest in learning more about Oncuria, Nonagen Bioscience’s innovative liquid biopsy for bladder cancer.

Oncuria is designed to test for certain proteins known to assist in determining the risk score of bladder cancer from urinary specimens. It is available as a laboratory developed test (LDT) through DiaCarta Laboratory. Nonagen Bioscience is currently seeking US Food and Drug Administration (FDA) approval for Oncuria as an in vitro diagnostic test.

The FDA granted Oncuria Breakthrough Device designation in September 2021 for predicting the response to bacillus Calmette-Guérin (BCG) therapy, a first-line treatment for bladder cancer. 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 Breakthrough Device designation enables close collaboration with, and expedited review by, the FDA and provides formal acknowledgement of Oncuria’s utility and potential clinical benefit.  

 

Published Research: Cancer Biomarkers

“Application of a multiplex urinalysis test for the prediction of intravesical BCG treatment response: a pilot study”

Authors: Kaoru Murakami, Ashish M. Kamat, Yunfeng Dai, Ian Pagano, Runpu Chen, Yijun Sun, Amit Gupta, Steve Goodison, Charles J. Rosser, and Hideki Furuya

Oncuria’s potential to predict response to BCG is especially meaningful given the global shortage of BCG and the fact that there are no reliable tests capable of predicting response to BCG therapy. A pilot study concluded that through voided urine samples, Oncuria’s 10-biomarker panel “enabled the discrimination of patients who did not respond to intravesical BCG therapy.”

 

Published research: Journal of Translational Medicine

“Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer” 

Authors: Yosuke Hirasawa, Ian Pagano, Runpu Chen, Yijun Sun, Yunfeng Dai, Amit Gupta, Sergei Tikhonenkov, Steve Goodison, Charles J. Rosser, and Hideki Furuya

This peer-reviewed research paper concluded that Oncuria “can achieve efficient and accurate detection and monitoring of bladder cancer in a non-invasive patient setting.”

 

Published research: Diagnostics

“Clinical utility of Oncuria™, a multiplexed liquid biopsy for the non-invasive detection of bladder cancer—a pilot study”

Authors: Kaoru Murakami, Ian Pagano, Hideki Furuya, Timothy Daskivich, Dave Mori, and Charles J. Rosser

In this pilot study, researchers found that Oncuria “can reduce the number of unnecessary invasive and non-invasive diagnostics recommended by physicians, which has the potential to lower healthcare costs and improve outcomes for patients.” 

 

THE ONCURIA WHITE PAPER

“Urine-based bladder cancer diagnostic: Oncuria™”

Learn how the Oncuria multiplex immunoassay was developed and how it compares to existing urine-based tests for bladder cancer management.

 

Order the test

Oncuria is now available as an LDT through DiaCarta, a GMP-compliant, CLIA-certified laboratory.

 

Questions?

To learn more about Oncuria and the research behind it, please email us at info@nonagen.com.

For Oncuria laboratory inquiries, please contact a DiaCarta Support Specialist at (800) 246-8878.

 
 

CLIA, Clinical Laboratory Improvement Amendments; GMP, Good Manufacturing Practice.