Precision in Action: Nonagen Bioscience Advances Bladder Cancer Detection with R&D Systems Luminex Assays
"When we set out to build a better diagnostic tool, we needed an assay solution that delivered both sensitivity and scalability. R&D Systems Luminex Assays gave us that—and more. It’s been essential to making Oncuria a clinical reality."
- Charles Rosser, MD, MBA, CEO, Nonagen Bioscience
Bladder cancer is the sixth most common cancer in the United States and one of the most recurrent. Despite its prevalence, a major clinical gap persists, as there are no approved diagnostics capable of reliably detecting the disease before symptoms arise.
Nearly 30% of patients are first diagnosed at Stage 2 or beyond, where the five-year survival rate drops to 50%. And for those treated early, recurrence remains a constant concern—up to 77% of early-stage tumors return, often requiring repeated interventions.
Recognizing this unmet need, Nonagen Bioscience set out to develop a more accurate and proactive approach to bladder cancer detection. Their solution? Oncuria®—a first-of-its-kind, multiplex urine test powered by multiplex assays from R&D Systems™.
Oncuria from Nonagen: A Smarter Tool
At the core of Oncuria is a proteomic signature: a panel of 10 proteins linked to bladder cancer biology. Unlike genomic or mRNA-based assays, which can be limited by tumor heterogeneity and sample quality, protein biomarkers are stable, well-characterized, and detectable in urine—making them ideal for non-invasive diagnostics.
But detecting these proteins, especially at low concentrations, demands high sensitivity and precise quantification across a dynamic range. That’s where R&D Systems’ Luminex Assays played a critical role.
“We evaluated multiple platforms, but the performance of R&D Systems Luminex Assays stood out,” said Dr. Charles Rosser, MD, MBA., CEO, Nonagen Bioscience. “They gave us the sensitivity to detect low-abundance targets and the multiplexing capability to measure all ten biomarkers in a single run—without sacrificing accuracy.”
Using high-quality reagents from R&D Systems, Nonagen validated Oncuria in over 4,300 patients, achieving 93% sensitivity and 95% specificity for bladder cancer detection.
| AUROC | Sensitivity | Specificity | |
|---|---|---|---|
| Overall | 0.95 | 0.93 | 0.93 |
| Low-grade tumors | 0.94 | 0.89 | 0.93 |
| High-grade tumors | 0.95 | 0.94 | 0.93 |
| Low-grade tumors (NMIBC) | 0.93 | 0.93 | 0.93 |
| High-grade tumors (MIBC) | 0.97 | 0.94 | 0.93 |
A Smarter Tool
For clinicians, Oncuria offers more than early detection. It also provides valuable insights into treatment selection and disease monitoring—especially for patients undergoing Bacillus Calmette-Guerin (BCG) therapy, the current first-line treatment for early-stage bladder cancer.
Yet BCG therapy is far from perfect: over 50% of patients fail to respond, and in some, the disease progresses. Oncuria’s multiplex signature helps stratify risk and predict response to therapy, giving urologists a new level of confidence in guiding care.
“Being able to non-invasively monitor patients over time is a game changer,” said Rosser. “With Luminex, we can quantify these protein signals consistently across patient visits, which supports not just diagnosis, but long-term disease management.”
Building for Clinical Scale
Oncuria was granted FDA Breakthrough Device Designation in 2021 for its ability to predict response to BCG therapy, accelerating its path to clinical availability as a Laboratory Developed Test (LDT). Nonagen’s choice to partner with R&D Systems reflects a strategic alignment around scientific rigor, regulatory experience, and manufacturing scalability.
“R&D Systems’ decades of immunoassay expertise gave us the confidence we needed to push forward,” said Rosser. “They’ve been instrumental in helping us translate biomarker discovery into a reliable clinical tool.”
Today, Oncuria is positioned not just as a diagnostic innovation, but as a paradigm shift in bladder cancer management—delivering accurate, reproducible data through a simple urine test, thanks in large part to the robustness of the Luminex platform.
Powering the Future of Proteomic Multiplexing in Oncology
With their success in bladder cancer, Nonagen is already exploring the broader potential of proteomic multiplexing in oncology.
“We believe multiplex protein assays like Oncuria represent the future of precision diagnostics,” said Rosser. “And with multiplex assay technology from R&D Systems, that future is within reach.”
By empowering clinicians with earlier, more accurate data, Nonagen and R&D Systems are working to change the trajectory of cancer care—one protein signature at a time.