By Marcha van der Steen

Multiplex tests allow for detection of bladder cancer and prediction of treatment response

What is hematuria and why it matters in bladder cancer detection

While hematuria, or blood in the urine, is one of the early indicators of bladder cancer, it’s also present in many patients who do not have cancer. Unfortunately, the standard-of-care test used to confirm the presence of bladder cancer is cystoscopy: a highly invasive procedure that many patients avoid, even when it’s recommended.

For those who are diagnosed with bladder cancer, there’s another hurdle: the immunotherapy often used in treatment, Bacillus Calmette-Guérin (BCG), doesn’t work at all in about half of patients. With frequent shortages of BCG, doctors need a better way to allocate limited doses.

Introducing Oncuria^®: a non-invasive bladder cancer test

¹ Nonagen Bioscience is currently seeking FDA approval for Oncuria as an in vitro diagnostic test.

To improve detection of bladder cancer and predict which patients will benefit from BCG treatment, scientists at Nonagen Bioscience developed the Oncuria^® suite of tests. At our recent xMAP^® Connect Virtual Event, Nonagen CEO Charles Rosser offered attendees an update on the development and validation of these clinical diagnostic tests.

Rosser began with a look at the landscape of testing options for suspected bladder cancer, citing at least 10 assays. “We have a lot out there,” he said, “but they’re not very good.” The widely used urinary cytology tests, about 1.5 million of which are run in CLIA labs every year, have a sensitivity of about 35%, he added. Many tests are based on a single biomarker, limiting their utility and predictive value.

How Nonagen developed a multiplex urine test for bladder cancer

At Nonagen, scientists developed a multiplex urine test focused on 10 proteins. These were originally run on 10 separate ELISAs; however, that cumbersome approach was difficult to translate to clinical use. At one point, the team had explored an immunoassay multiplexing technology but eventually abandoned it when years of development still hadn’t led to a clinical assay.

Why xMAP^® Technology improves bladder cancer test accuracy

With the help of scientists at Bio-Techne, Nonagen ported the test to xMAP^® Technology. The xMAP-based test yielded better results, with sensitivity of 93% and specificity of 95%, compared to 85% and 80%, respectively, with the previous platform. Rosser said it proved to be a significant advantage because xMAP Technology instruments are so widely used in clinical laboratories, making it easier for prospective customers to implement the Nonagen test. To ensure broad use, scientists compared results across various xMAP platforms and found excellent concordance.

Clinical validation of Oncuria^® for bladder cancer diagnosis

Rosser’s presentation also walked through the studies Nonagen has performed over the years to reach the point of having a clinical diagnostic test. Collectively, there are now more than 30 peer-reviewed publications analyzing results from at least 5,000 patients. The newest study, which has not yet been published, demonstrates that the Oncuria^® test can predict which patients will respond to BCG treatment, a feat that could make it possible to “bring this [therapy] into the era of precision medicine,” Rosser said.

Medicare-covered Oncuria^® tests for bladder cancer management

Nonagen announced in January of 2024  that Medicare payment rates were determined for all three of their laboratory-developed Oncuria^® tests designed to detect bladder cancer, monitor disease recurrence, and predict response to BCG treatment. “Oncuria^® has the potential to cause a major shift in how bladder cancer is managed,” Rosser said.

 

Curious to learn how multiplex technology helps labs optimize and streamline diagnostic testing? Read more from our website:

• xMAP^® Education Hub: This page serves as a central resource for learning about xMAP Technology, including blogs, webinars, and white papers. It’s ideal for readers interested in the science behind multiplexing and how it supports clinical diagnostics like Oncuria^®’s assay.
• Technology Overview: xMAP^® Multiplexing Platform: This article explains how xMAP Technology enables high-throughput testing of up to 500 analytes, with applications in immunoassays and nucleic acid-based diagnostics. It’s a great link for readers wanting to understand the platform used in Nonagen’s Oncuria^®.
• Automation of xMAP^® Technology-Based Multiplex Assays (White Paper): This whitepaper explores how automation enhances the efficiency and scalability of xMAP Technology-based multiplex assays. It highlights benefits such as reduced sample consumption, faster reaction times, and improved throughput, all critical for clinical labs working with bladder cancer diagnostics.
• Expanded Performance Comparison of the Oncuria 10-Plex Bladder Cancer Urine Assay Using Three Different Luminex xMAP Instruments: This paper presents a study evaluating the clinical performance of the Oncuria^® 10-Plex bladder cancer urine assay across three Luminex xMAP platforms: FLEXMAP 3D^®, Luminex^® 200™, and MAGPIX^® System in an expanded cohort of 181 subjects, including 54 with confirmed bladder cancer.