TEST:

Oncuria™

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.

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.

"DiaCarta proudly announced that the Oncuria Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024...Oncuria-Detect: Designed for the detection of bladder cancer, providing accurate and reliable results to aid in early diagnosis and treatment planning; Oncuria-Monitor: Enables the monitoring of bladder cancer recurrence, offering physicians valuable insights for disease management and surveillance; Oncuria-Predict: Revolutionizes the prediction of BCG therapy response for non-muscle invasive bladder cancer (NMIBC) patients, empowering clinicians with personalized treatment strategies."

P=N/A; Multiplex BC assays generate detailed molecular signatures useful for identifying BC, predicting treatment responsiveness, and tracking disease progression and recurrence. The similar performance of the Oncuria assay across three different analyzer systems supports test adaptation by clinical and research laboratories using existing xMAP platforms.

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.

Oncuria TM data was evaluated in voided urine samples obtained from a prospectively collected cohort of 18 subjects who have BCG-unresponsive NMIBC with treatment of atezolizumab monotherapy or atezolizumab BCG combination (provided by Genentech, NCT02792192)... Previous pilot study found that monitoring the urinary levels of a cancer-associated biomarker panel enabled the discrimination of patients who did not respond to intravesical BCG therapy. In this study, we noted the performance of Oncuria TM for the prediction of systemic PDL1 inhibitor treatment response. A limitation of this study includes its small sample size.

In this study, we tested the performance of OncuriaTM in a BCG unresponsive cohort to determine if it could predict response to a PDL1 inhibitor. OncuriaTM data was evaluated in voided urine samples obtained from a prospectively collected cohort of 18 subjects who have BCG-unresponsive NMIBC with treatment of atezolizumab monotherapy or atezolizumab BCG combination (provided by Genentech, NCT02792192)... Previous pilot study found that monitoring the urinary levels of a cancer-associated biomarker panel enabled the discrimination of patients who did not respond to intravesical BCG therapy. In this study, we noted the performance of OncuriaTM for the prediction of systemic PDL1 inhibitor treatment response. A limitation of this study includes its small sample size.

"DiaCarta, Ltd...announced the successful completion of the validation study of Oncuria^® multiplex bladder cancer immunoassay as a laboratory developed test ('LDT'). DiaCarta also announced that it has begun receiving patient urine samples for testing in its CLIA certified lab in Pleasanton, California."

 Urinary levels of a biomarker panel enabled the accurate discrimination of bladder cancer patients and controls. The multiplex Oncuria™ test can achieve the efficient and accurate detection and monitoring of bladder cancer in a non-invasive patient setting.

It has achieved a sensitivityof 93% for the detection of bladder cancer and achieved an accuracy of 82% in a diagnostic nomogram forpredicting response to intravesical BCG therapy. Biomarkers: VEGF-A MMP-9 IL-8 ANG MMP-10 CA9 PAI-1SERPIN E1 SDC1 APOE A1AT SERPIN A.

It has achieved a sensitivity of 93% for the detection of bladder cancer and achieved an accuracy of 82% in a diagnostic nomogram for predicting response to intravesical BCG therapy. Biomarkers: VEGF-A MMP-9 IL-8 ANG MMP-10 CA9 PAI-1 SERPIN E1 SDC1 APOE A1AT SERPIN A.

The analysis of three independent, publicly available gene expression datasets confirmed that multiplex prognostic models outperformed single biomarkers. In total, 8 of the 10 biomarkers from the Oncuria™ test were significantly associated with either luminal or basal molecular subtypes, and thus, the test has the potential to assist in the prediction of clinical outcome.

"Nonagen Bioscience...announced CE marking for its Oncuria® immunoassay for bladder cancer...Oncuria now bears the CE marking and is registered under the EU In Vitro Diagnostic Directive (IVDD), EU Directive 98/79/EC, which allows Nonagen to sell the diagnostic in the European market."

"Nonagen Bioscience and Bio-Techne Corporation...announced an agreement for R&D Systems, a Bio-Techne brand, to exclusively manufacture Nonagen Bioscience’s Oncuria® bladder cancer diagnostic panel using xMAP Luminex® technology...Nonagen Bioscience and Bio-Techne are targeting the last quarter of calendar 2022 to make Oncuria available as an LDT."

We are currently performing a validation study with a larger retrospective cohort of ~120 subjects with intermediate or high risk NMIBC prior to treatment with intravesical BCG. The results will be presented in the AUA 2022.

"Peregrine Market Access...has been selected by Nonagen Bioscience to become its contract commercialization organization for Oncuria, a breakthrough bladder cancer diagnostic test that is being developed to aid in detection, therapy choice, and disease monitoring. Under a multiyear, multimillion dollar agreement, Peregrine Market Access will lead the United States launch of Oncuria."

Monitoring the urinary levels of a cancer-associated biomarker panel enabled the discrimination of patients who did not respond to intravesical BCG therapy. With further study, the multiplex OncuriaTM test may be applicable for the clinical evaluation of bladder cancer patients considering intravesical BCG treatment.

The Oncuria™ multiplex test performed well in the ex vivo experimental model and shows promise for clinical application. The identification of patients who require additional clinical evaluation could reduce the need to subject patients who do not have bladder cancer to frequent, uncomfortable and expensive cystoscopic examinations, thus benefiting both patients and the healthcare system.

"Urinary levels of a biomarker panel enabled the accurate discrimination of bladder cancer patients and controls. The multiplex Oncuria™ test can achieve the efficient and accurate detection and monitoring of bladder cancer in a non-invasive patient setting."