Introducing Oncuria®

A next-generation oncology diagnostic

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.

Bladder cancer is a highly recurrent type of cancer. In fact, up to 77% of early-stage bladder tumors treated with current approaches (tumor resection and/or intravesical bacillus Calmette-Guérin [BCG] or chemotherapy) will recur.¹ More than half of patients who receive BCG as the first-line treatment for bladder cancer will fail to respond, and in 20% of patients the disease grows and extends during or after BCG therapy.2,3

A reliable urine test for improved bladder cancer management

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, enabling a more effective approach to cancer detection.

In clinical studies, Oncuria was shown to have 93% sensitivity and 93% specificity for detecting bladder cancer.⁴ Additionally, Oncuria has demonstrated consistent sensitivity and specificity across bladder cancer tumor grades and stages.⁴ 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.

DiAGNOSE, PREDICT, MONITOR

The Oncuria assay and proprietary algorithms that use the 10-biomarker molecular signature are being investigated to:

  • Aid in the diagnosis of bladder cancer

  • Monitor people with early-stage bladder cancer for recurrence

  • Predict whether patients with intermediate- to high-risk, early stage bladder cancer will respond to BCG therapy

In September 2021, Oncuria received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for predicting the response to BCG therapy. That designation acknowledges the utility and potential clinical benefit of Oncuria and allows for expedited review with the FDA.

Sensitivity

Oncuria is a bladder cancer diagnostic that is sensitive enough for patients with low-grade or early-stage bladder cancer.

Oncuria demonstrated high sensitivity in detecting various stages and grades of bladder cancer.5-7

 
 

Intended Use

Oncuria is designed to detect 10 proteins in a multiplex immunoassay in urine specimens from people with hematuria suspected of having bladder cancer or urine specimens from people with a history of bladder cancer on tumor surveillance. 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.

Limitations

  1. Oncuria has been optimized for quantitating 10 proteins in human urine specimens.

  2. The performance of Oncuria was validated using the procedures provided in its package insert only. Modifications to these procedures may alter the performance of the assay. 

  3. The clinical interpretation of any test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results. 

  4. Oncuria assay results may not be informative if the specimen is from an individual with renal impairment.

  5. If Oncuria results are negative but standard clinical or diagnostic tests (eg, cytology, cystoscopy) are positive, the standard procedures take precedence over the Oncuria test.

Nonagen Bioscience is currently seeking FDA approval for Oncuria as an in vitro diagnostic test. Oncuria is available as a laboratory developed test (LDT) through DiaCarta, a GMP-compliant, CLIA-certified laboratory.


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Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; GMP, Good Manufacturing Practice.

References: 1. Ritch CR, Velasquez MC, Kwon D, et al. Use and validation of the AUA/SUO risk grouping for non-muscle-invasive bladder cancer in a contemporary cohort. J Urol. 2020;203(3):505-511. doi:10.1097/JU.0000000000000593 2. Witjes JA. Management of BCG failures in superficial bladder cancer: a review. Eur Urol. 2006;49(5):790-797. doi:10.1016/j.eururo.2006.01.017 3. Matulay JT, Li R, Hensley PJ, et al. Contemporary outcomes of patients with non-muscle-invasive bladder cancer treated with bacillus Calmette-Guérin: implications for clinical trial design. J Urol. 2021;205(6):1612-1621. doi:10.1097/JU.0000000000001633 4. Hirasawa Y, Pagano I, Chen R, et al. Diagnostic performance of Oncuria™, a urinalysis test for bladder cancer. J Transl Med. 2021;19(1):141. doi:10.1186/s12967-021-02796-4 5. Goodison S, Ogawa O, Matsui Y, et al. A multiplex urinary immunoassay for bladder cancer detection: analysis of a Japanese cohort. J Transl Med. 2016;14(1):287. doi:10.1186/s12967-016-1043-1 6. Shimizu Y, Furuya H, et al. A multiplex immunoassay for the non-invasive detection of bladder cancer. J Transl Med. 2016;14:31. doi:10.1186/s12967-016-0783-2 7. Grossman HB, Messing E, Soloway M, et al. Detection of bladder cancer using a point-of-care proteomic assay. JAMA. 2005;293(7):810-816. doi:10.1001/jama.293.7.810