Cancer diagnostics company Nonagen Bioscience has received a CE mark for their bladder cancer diagnostic test, Oncuria, granting the test approval to be sold in the European market. Oncuria is a urine test that can detect 10 bladder cancer biomarkers in urine.
“The CE mark demonstrates the quality of the Oncuria test, which reflects years of rigorous clinical development by an exceptional team,” said Charles J. Rosser, MD, MBA, CEO and chief medical officer at Nonagen Bioscience. “This is a significant first step on the path to the global commercialization of Oncuria.”
According to the American Cancer Society, in the United States, about 81,180 new cases of bladder cancer will be diagnosed in 2022, and about 17,100 deaths from bladder cancer will occur. Worldwide, bladder cancer is the tenth most common form of diagnosed cancer.
Almost half of all bladder cancers are discovered when the cancer is still only in the inner layer of the bladder wall. During this early phase, the cancer can be detected in specific cancer proteins that may be found in urine samples. Oncuria is a multiplex test that can detect 10 proteins that are commonly found in urine when bladder cancer is present. Oncuria is intended to detect early bladder cancer in patients who present with blood in their urine or with a familial history of the disease.
A diagnostic trial to measure the performance of Oncuria was conducted by Hirasawa Y, Pagano I, Chen R, et al. The trial was comprised of 362 people presenting with bladder cancer, and each subject was tested for 10 different bladder cancer proteins using Oncuria. The results showed that the test has a 93% sensitivity rate and a 93% specificity rate for detecting bladder cancer, determining that Oncuria can achieve “efficient and accurate detection and monitoring of bladder cancer in a non-invasive patient setting.”
Switching from single-use diagnostic biomarkers to multiplex tests such as Oncuria can help create easier patient evaluation processes for diagnosing bladder cancer. As opposed to using multiple tests to detect single proteins, tests like Oncuria can detect multiple proteins at once.
Oncuria’s developers, Nonagen Bioscience, are based in Los Angeles and are aiming to launch the test in the United States in the final quarter of 2022. Pending FDA approval, the company plans to make Oncuria available as an in vitro diagnostic.