First-of-Its-Kind Multiplex Protein-Based Urine Test Detects Bladder Cancer

As a highly recurrent disease, bladder cancer is a major health concern that places an immense burden on healthcare systems. Up to 77% of early-stage bladder tumors that are treated with current approaches (tumor resection and/or intravesical BCG or chemotherapy) will recur. More than half of patients who receive Bacillus Calmette-Guérin (BCG) therapy as the first-line treatment for bladder cancer will fail to respond. In addition, in 20% of patients, the disease grows and extends during or after BCG therapy. Now, a first-of-its-kind multiplex protein-based urine test that provides early and accurate detection, therapy choice, and disease monitoring of bladder cancer can help improve patient outcomes.

Nonagen Bioscience Corporation (Los Angeles, CA, USA) has entered into an agreement with Bio-Techne Corporation (Minneapolis, MN, USA) to exclusively manufacture its Oncuria bladder cancer diagnostic panel using xMAP Luminex technology. The Luminex-based multiplex assay panel combines Bio-Techne's high-quality reagents with Nonagen's diagnostic expertise to create a powerful solution to advance bladder cancer treatment strategies. Nonagen’s lead diagnostic, Oncuria, is a breakthrough multiplex immunoassay for the quantitative detection of biomarkers in urine that are associated with the presence of bladder cancer.

Oncuria is designed to detect 10 proteins in a multiplex immunoassay in urine specimens from persons with hematuria suspected of having bladder cancer or urine specimens from persons with a history of bladder cancer on tumor surveillance. Unlike current urine-based technologies, such as cytology, fluorescent probes, and mRNA, bladder cancer tumor proteins are well understood in the scientific literature and readily identified in the urine, offering a more effective approach to cancer detection. In clinical studies, Oncuria was shown to have 93% sensitivity and 93% specificity for detecting bladder cancer. Additionally, Oncuria has demonstrated consistent sensitivity and specificity across bladder cancer tumor grades and stages. Oncuria’s high level of accuracy is especially meaningful for detecting low-grade tumors, which is an area of high unmet need in bladder cancer management.

Results from Oncuria are intended for use, in conjunction with, not in lieu of, current standard diagnostic procedures as an aid for initial diagnosis of bladder cancer in patients with hematuria, and for subsequent monitoring of tumor recurrence in patients previously diagnosed with bladder cancer. In September 2021, the US FDA had granted Oncuria a Breakthrough Device Designation for predicting response to BCG therapy, a first-line treatment for bladder cancer. Nonagen and Bio-Techne are targeting the last quarter of calendar 2022 to make Oncuria available as an LDT.

"We're excited to partner with Bio-Techne to make Oncuria available as a laboratory developed test (LDT), given their extensive biomarker discovery expertise," said Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "Bio-Techne also shares our passion for translating research discoveries into innovative diagnostics, to improve the detection and management of cancer."

"We look forward to working with Nonagen to develop this game-changing immunoassay in the fight against bladder cancer," said Will Geist, President of Bio-Techne's Protein Sciences division. "Nonagen's deep experience in diagnostic and testing research is complementary to Bio-Techne's extensive immunoassay expertise and world-class manufacturing capabilities, creating an ideal partnership for this important bladder cancer detection assay."

Related Links:
Nonagen Bioscience Corporation 
Bio-Techne Corporation