TEST:

Oncuria™

Oncuria-Detect accurately identified and categorized UTUC and discriminated patients with cancer from non-tumor bearing individuals. The Oncuria-Detect test provides a rapid, accurate, and non-invasive method for detecting UTUC.

The HCRS achieves strong predictive power for the detection of bladder cancer in patients undergoing hematuria work up. The addition of the Oncuria-Detect test provides incremental improvement to this performance. Both tests can be performed at the initial primary care encounter for hematuria and may improve patient selection for cystoscopy.

The Oncuria BC assay generates comprehensive urinary protein signatures useful for assisting BC diagnosis, predicting treatment response, and tracking disease progression and recurrence. The equivalent performance of the multiplex BC assay using three popular analyzers rationalizes test adoption by CLIA (Clinical Laboratory Improvement Amendments) clinical and research laboratories.

"Nonagen Bioscience...announced today several strategic milestones as it positions for its next phase of growth. As the completion of pivotal clinical trials draws near for its Oncuria® suite of bladder cancer tests, including Oncuria-Detect™ and Oncuria-Monitor™, the company has multiple FDA submissions in the works and plans to expand its clinical partnerships. Recent collaboration with large national laboratory provider signals growing market interest in precision, non-invasive diagnostics for urologic oncology. Nonagen has also broadened its pipeline with the development of Nexus-Dx™, a neoadjuvant chemotherapy response predictor for bladder cancer, and FibraChek™, a novel non-invasive test for assessing liver fibrosis in at-risk populations."

The multiplex Oncuria assay identified bladder cancer with high sensitivity and NPV. Oncuria's high NPV could effectively rule out 66% of patients from requiring subsequent cystoscopy.

P2, N=20, Recruiting, Leslie Ballas | Not yet recruiting --> Recruiting

Therefore, we could not identify a suitable biospecimen stabilizer that would not require sample refrigeration. To minimize sample degradation/alteration after collection, voided urine samples should be refrigerated until analyzed with Oncuria as the refrigeration is advantageous for the storage and the transport of these urine samples.

P2, N=20, Not yet recruiting, Leslie Ballas | Initiation date: Jul 2024 --> Feb 2025

P2; N=20; Not yet recruiting; Sponsor:Leslie Ballas

Urinary levels of a biomarker panel enabled the accurate discrimination of UTUC and controls non-tumor bearing individuals. The multiplex Oncuria-Detect® test can achieve the efficient and accurate detection of UTUC in a non-invasive patient setting.

In conclusion, the Oncuria BC assay performed similarly well across three different flow analysis platforms for all 10 analytes simultaneously evaluated in urine samples. This agreement across instruments indicates that the test is amenable to standardized performance in laboratories using existing xMAP, without requiring costly outlays for new equipment.