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Bladder Cancer

Being among the five most common malignancies worldwide, bladder cancer is a major cause of morbidity and mortality, and a great burden to healthcare systems. Due to a high disease recurrence rate, patients are under continued surveillance for early detection of new tumor developments and face undergoing multiple invasive procedures.  Consequently, The development of accurate assays that can detect and monitor bladder cancer non-invasively through urinalysis would be a major advance, benefiting both patients and healthcare systems. Through our proteomics and genomics programs, we have identified a diagnostic molecular signature that can be applied to detect bladder cancer in voided urine samples.  Through multiple validation studies, technological developments, and engagement with the FDA, we are now poised to begin clinical trials to refine and establish a clinical laboratory test that can guide clinical management of patients at risk for bladder cancer.     

 

       Early Detection is critical for improved survival

 

INFORMATION

Sensitivity

Oncuria™ (1,2) is more sensitive for bladder cancer detection than urine cytology (3) for both disease stage and by grade.

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Intended Use

Oncuria™ is designed to detect 10 proteins by ELISA 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. Results from Oncuria™ are intended for use, in conjunction with, and 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 this 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 (e.g., cytology, cystoscopy) are positive, the standard procedures take precedence over the Oncuria™test.

 

FOR RESEARCH PURPOSES ONLY - This test was developed and its performance characteristics determined by Nonagen Bioscience Corp. It has not been cleared or approved by the FDA.

 

References:

1.     Goodison S, Ogawa O, Matsui Y, Kobayashi T, Miyake M, Ohnishi S, Fujimoto K, Dai Y, Shimizu Y, Tsukikawa K, Furuya H, Rosser CJ. A multiplex urinary immunoassay for bladder cancer detectiuon: analysis of a Japanese cohort. J Transl Med. 2016 Oct 7;14(1):287.

2.     Shimizu Y, Furuya H, Bryant Greenwood P, Chan O, Dai Y, Thornquist MD, Goodison S, Rosser CJ. A multiplex immunoassay for the non-invasive detection of bladder cancer.  J Transl Med. 2016 Jan 30;14:31. doi: 10.1186/s12967-016-0783-2.

3.     Grossman HB, Messing E, Soloway M, Tomera K, Katz G, Berger Y, Shen Y. Detection of bladder cancer using a point-of-care proteomic assay. JAMA. 2005 Feb 16;293(7):810-6.