Developing a Highly Sensitive Urine Test for Bladder Cancer


  • Non-invasive technology/Keratin 17 novel biomarker
  • Most sensitive and accurate cancer [Babu et al., 2019, Vasdev et al., 2020]
  • Cost-effective
  • World-wide market presence : US market – LDT, OUS – CE-IVD
  • Link to URO17 test website
    • Early detection
    • Monitoring
    • Guide Therapy

Keratins are intermediate filaments that display a broad range of molecular diversity and undergo tight regulation in a tissue specific, differentiation-related, and context-dependent manner. Keratin 17 (K17), although not present in a significant amount in normal mature epithelia, it is elevated in carcinomas, and recently was shown to act as an oncoprotein by regulating the subcellular localization and degradation of p27KIP1 (1).

Babu et al., 2019 study was performed with 112 prospectively collected urine samples from two US urology sites (one hospital-based, one community clinic) between 2016-2018 (2).   The samples were mainly from patients with previously diagnosed urothelial cancer coming into the clinic for a routine monitoring examination. These samples were tested by URO17® and routine cytology, and results were confirmed by cystoscopy and biopsy.

The results showed that URO17® had 100% Sensitivity and 96% Specificity (91% PPV, 100% NPV) in detection of urothelial cancer cells in urine cytology samples; the comparative cytology results are also shown (Table 1).

In the same study, 109 formalin-fixed paraffin-embedded tissue blocks from patients who received care at the hospital site between 1995-2017 were retrospectively selected and tested for K17 expression with the URO17® test. The data demonstrated significant overexpression of K17 in both low-grade and high-grade lesions and invasive urothelial cancer (Fig 1) showing the utility of URO17® in detecting all stages and grades of urothelial cancer.

Another study Vasdev et al., (2020) was conducted on 71 patients with hematuria at the Lister Hospital in London, UK (3).

The results (Table 2) showed that URO17® identified all 44 cases of clinically confirmed urothelial carcinoma (100% sensitivity) with 92.6% of cystoscopy negative patients being negative for URO17®. The malignancies detected included both muscle-invasive and non-muscle-invasive tumors, and tumors of all grades and carcinoma in situ. These data confirm the original findings and demonstrate that the URO17® test utilizing K17 biomarker can be used to identify bladder cancer in patients with hematuria with no prior history of bladder cancer.

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  1. Escobar-Hoyos LF, Shah R, Roa-Pena L, et al. Keratin-17 Promotes p27KIP1 Nuclear Export and Degradation and Offers Potential Prognostic Utility. Cancer research. 2015;75(17):3650-62.
  2. Babu S, Mockler DC, Roa-Peña L, et al., Keratin 17 is a sensitive and specific biomarker of urothelial neoplasia. Mod Pathol. 2019 May;32(5):717-724.
  3. Vasdev N, Hampson A, Agarwal S, et al. The role of URO17™ biomarker to enhance diagnosis of urothelial cancer in new hematuria patients—First European Data. BJUI Compass. 2021; 2:46–52.