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Subspecialties Cytology, Screening and monitoring, Oncology, Biochemistry and molecular biology

A Better Future for Bladder Cancer

sponsored by Acupath Labs

Bladder cancer presents a diagnostic challenge for even the best pathologists and laboratory medicine professionals. With symptoms similar to those of other urinary tract conditions and no reliable screening tests to spot malignancy, patients may experience delays in diagnosis. And these delays can affect survival – almost 90 percent of those diagnosed at stage I survive five years or more, whereas only about 10 percent of those diagnosed at stage IV achieve the same survival. To provide patients with the best possible chances, diagnostic professionals need sensitive, specific tests for bladder cancer – a problem to which URO17™ offers an effective and noninvasive solution.

The promise of URO17

A sensitive and specific biomarker for bladder cancer, URO17™ is a noninvasive, cost-effective diagnostic tool that I believe can revolutionize how the disease is detected and treated (1) (see Figure 1). It is currently being used in conjunction with traditional urine cytology, which requires a simple voided urine collection and is indicated for patients at high risk for bladder cancer.

[URO17™] achieved a sensitivity of 100 percent and specificity of 96 percent in urine specimens and a sensitivity of 89 percent and specificity of 88 percent in tissue specimens.

Urine cytology, traditionally the most commonly used test for bladder cancer, is largely ineffective; its sensitivity for the disease is below 40 percent and the American Urological Association (AUA) has even advised against its use as part of the routine evaluation of microhematuria. Another commonly used diagnostic testing methodology, fluorescence in situ hybridization (FISH), can detect chromosomal abnormalities linked to bladder cancer – but although it offers more reliable results than cytology, FISH is significantly more expensive and remains ineffective at detecting low-grade tumors.

In published studies, URO17™ has proven to be highly sensitive and specific, achieving a sensitivity of 100 percent and specificity of 96 percent in urine specimens and a sensitivity of 89 percent and specificity of 88 percent in tissue specimens (2). In addition, the marker identifies both low- and high-grade tumors at a significantly lower cost than FISH.

Figure 1. Accuracy of URO17™ in diagnosing urothelial carcinoma (UC) in patients at risk of the disease. Among 39 cases with final clinicopathologic diagnosis, URO17™ ICC was positive in all 39 cases. At least 10 immunoreactive urothelial cells were detected in each cytologically malignant urine specimen with biopsy-confirmed UC.

Real world use

Who might be suitable for URO17™ testing? Anyone suspected of being at risk for bladder cancer. If a patient experiences gross or microscopic hematuria, frequent or painful urination, exhibits any familial or historical risk, is a smoker, or is over 50, then it is worth testing for the disease. Prevention is better than a cure.

Most labs already have the instrumentation required to run the marker in-house, so adding URO17™ testing should not cause any workflow issues.

As an immunocytochemistry (ICC) stain, URO17™ can easily be incorporated into any lab’s bladder cancer detection program. Most labs already have the instrumentation required to run the marker in-house, so adding URO17™ testing should not cause any workflow issues. However, for those not yet prepared to bring the test fully in-house, URO17™ is also available on both a technical component (slide preparation only) and global (final report issued) basis – and when laboratories are ready to take the next step, Acupath is happy to assist with every step of that process.

Next steps

Since its debut, the URO17™ test has taken off and the feedback has been overwhelmingly positive. Why? Because urologists, pathologists, and laboratory professionals all recognize the significant shortfalls of traditional urine cytology testing. Providers are eager to leverage this new tool, especially considering its noninvasive collection, cost-effectiveness, and minimal (if any) disruption to workflow.

Because the AUA has discouraged the use of urine cytology in recent years, many urologists have significantly decreased their reliance on it or stopped ordering it entirely. URO17™ offers the opportunity to significantly improve on traditional urine cytology without the need to subject patients to a painful and invasive cystoscopy. I believe that URO17™ will give us back the ability to noninvasively screen for bladder cancer – with the assurance that we can trust the results we receive.

Acupath offers URO17™ through a semi-exclusive licensing agreement with KDx Diagnostics Inc., Campbell, USA.

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  1. S Babu et al., “Validation of a novel cytologic biomarker for urothelial carcinoma”. Poster presented at Bladder Cancer: Transforming the Field; May 20, 2019; Denver, USA. Poster #B01.
  2. S Babu et al., “Keratin 17 is a sensitive and specific biomarker of urothelial neoplasia”, Mod Pathol, 32, 717 (2019). PMID: 30443013.
About the Author
John Cucci

Chief Sales Officer at Acupath Laboratories Inc., Plainview, USA.

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